FEBRUARY 2002

WEEK ENDING FEBRUARY 2

 

PRODUCT Dimension Clinical Chemical Analyzer XL/RxL/ARx with software revision 5.2,

CODE Revision 5.2 The following serial numbers are involved in the recall: 971807, 973002, 970457, 973278, 970598, 970454, 970049, 971979, 973242, 970864, 973218, 970219, 973498, 970152, 950208, 971645, 970300, 950207, 972376, 970919, 970066, 970521, 971949, 972903, 971202,

973145, 972464, 973143, 971229, 971939, 973140, 973100, 973083, 971966, 970480, 950209, 970037, 972495, 972628, 971098, 971660, 972850, 971102, 971052, 972117, 972173, 970705, 972590, 971625, 971526, 973150, 970599, 972904, 973014, 970880, 970327, 971414, 970561, 971200, 971953, 972373, 971813, 972137, 971845, 973074, 972040, 971830, 970481, 972222, 970173, 971023, 972664, 970836, 990281, 971226, 970471, 970860, 970588, 973080, 973190, 973192, 972273, 973195, 970639, 973193, 973191, 950446, 970033, 972363, 970550, 970249, 972425, 970164, 970649, 973406, 971640, 971650, 971679, 972471, 972474, 972596, 970382, 972176, 972270, 971260, 950165, 971721, 972884, 972451, 950341, 971701, 970518, 972232, 970824, 971241, 972301, 970464, 970035, 971388, 973285, 972743, 973128, 971310, 970847, 990267, 990270, 973257, 971277, 972581, 971794, 973208, 971838, 950380, 972338, 970572, 971094, 973153, 971131, 972368, 970697, 972441, 972962, 973206, 970087, 972079, 973213, 970978, 973365, 973325, 950108, 950421, 973028, 972393, 973339, 990257, 950286, 971653, 972911, 972269, 972663, 970359, 970692, 970337, 972920, 970343, 970889, 970041, 970622, 970969, 971422, 971641, 970808, 970890, 972378, 971655, 971293, 970324, 970560, 971442, 970222, 972790, 971057, 971271, 970261, 970242, 970048, 970214, 971121, 970477, 950170, 970056, 972572, 970289, 970702, 971711, 972494, 970032, 970654, 971025, 970754, 973509, 970821, 990184, 972369, 972321, 971384, 971461, 971027, 971937, 972559, 970128, 971194, 971570, 971602, 950176, 971833, 970220, 972266, 970282, 970874, 973290, 970929, 970358, 971133, 973228, 971666, 971592, 970790, 970111, 971196, 971129, 973088, 971901, 972438, 973428, 973036, 971413, 971572, 971500, 990139, 990186, 971841, 972459, 971429, 990221, 973072, 973268, 972364, 973320, 971993, 972260, 971930, 972528, and 971829.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Dade Behring, Inc. Newark, DE

Manufacturer: Dade Behring, Inc. Brookfield, CT.

REASON Instructions to software revision are missing a step.

VOLUME OF PRODUCT IN COMMERCE 256 sets.

DISTRIBUTION Nationwide.

 

PRODUCT Ballard Cytology Brush Disposable

Cat. No. 60311, 1.8mm x 120 cm catheter, 2.0 mm bristle diameter

Cat. No. 60312, 1.8mm x 120 cm catheter, 3.0 mm bristle diameter

Cat. No. 60313, 1.8mm x 160 cm catheter, 2.0 mm bristle diameter

Cat. No. 60314, 1.8mm x 160 cm catheter, 3.0 mm bristle diameter,

CODE Catalog Numbers 60311, 60312, 60313, 60314.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Ballard Medical Products, Draper, UT

Manufacturer:  Ballard Medical Products, Pocatello, ID.

REASON Radiopaque distal tip may detach from the cytology brush.

VOLUME OF PRODUCT IN COMMERCE 33,802 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT ITI Dental Implant System Handpiece Adapters

CODE a) Catalog No. 046.470, Extra Short. Lot No, 1200; b) Catalog No. 046.471, Short. Lot No. 1200.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Straumann USA. Waltham, MA

Manufacturer:  Institut Strauman AG Waldenburg, Switzerland.

REASON Dental Handpiece Adapter fails specification and may remain lodged in the unit.

VOLUME OF PRODUCT IN COMMERCE 83 units. a) 78 units; b) 5 units.

DISTRIBUTION Nationwide.

 

PRODUCT ADAC brand Forte Gamma Camera System An Scintillation Gamma Camera, Tomography, Computed Emission

CODE Model numbers: 2155-3000, 3001, 3002, 3004, 3004, 3006.

RECALLING FIRM/MANUFACTURER ADAC Laboratories Milpitas, CA

REASON Collimator drawer could drop to the floor causing injury to the user/patient.

VOLUME OF PRODUCT IN COMMERCE 125 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Therapeutic Plasma Exchange Set

CODE LMT 193.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Fresenius HemoCare, Inc., Redmond, WA

Manufacturer:  Fresenius HemoCare GmbH, The Netherlands.

REASON Return line of tubing set smaller than normal.

VOLUME OF PRODUCT IN COMMERCE 1905 sets.

DISTRIBUTION Nationwide.

 

PRODUCT Lubricated latex condoms, model number 9030

CODE Lot number 0661123.

RECALLING FIRM/MANUFACTURER Alatech Healthcare, LLC Slocomb, AL

REASON Failed FDA leak testing.

VOLUME OF PRODUCT IN COMMERCE 109 cases of 1000.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT Apligraf(Graftskin)

CODE Lot #GS0111.06.02.1A  Exp. Date: December 7, 2002.

RECALLING FIRM/MANUFACTURER Organogenesis Inc. Canton, MA

REASON Product is contaminated with staphlococcus cohnii.

VOLUME OF PRODUCT IN COMMERCE 107 units.

DISTRIBUTION Nationwide.

 

PRODUCT ADAC brand Forte Gamma Camera System An Scintillation Gamma Camera, Tomography, Computed Emission

CODE Model #s: 2155-3000, 3001, 3002, 3004, 3004, 3006 Catalog #s: N-FT-3/8B, N-FT-5/8B, N-FT-MCDB.

RECALLING FIRM/MANUFACTURER Adac Laboratories Milpitas, CA

REASON A sensor may not activate if proper contact is not made.

VOLUME OF PRODUCT IN COMMERCE 125 units.

DISTRIBUTION Nationwide and internationally.

 

PRODUCT Polarus Broach.  Instrument belongs to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying  instrumention. The broach is reusable and provided non-sterile

CODE Lot # W03397.

RECALLING FIRM/MANUFACTURER Acumed, Inc., Beaverton, OR

REASON The word "lateral" was etched on the medial side of the broach.

VOLUME OF PRODUCT IN COMMERCE  27.

DISTRIBUTION United Kingdom, Finland, Spain and The Netherlands.

 

PRODUCT AxSYM Troponin-I Calibrators, list 3C29-01;6 bottles of calibrators A-F; Abbott Laboratories, Diagnostics Division, Abbott Park,

IL 60064.

CODE Calibrator lots 78883M300, Exp. 9/21/01; 78884M300 and 78884M301, exp. 11/1/01; 81410M100 and 81410M101, exp. 11/22/01.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc. Abbott Park, IL

REASON Incorrect High Control readout due to stability failures of the calibrators.

VOLUME OF PRODUCT IN COMMERCE 5,414 kits.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT MediVators brand Rapicide High-Level Disinfectant and Sterilant.  Active ingredient:  Glutaldehyde.

CODE Lots L101111, l101112, L101511.

RECALLING FIRM/MANUFACTURER Ecolab Inc. Huntington, IN

REASON Leaking bottles.

VOLUME OF PRODUCT IN COMMERCE Approx. 3,000 cases.

DISTRIBUTION MN.

 

PRODUCT Symmetry Aortic Connector System, Model Numbers CAN-4550

CODE Lots 53739, 54085, 54296, 54330, 54616.

RECALLING FIRM/MANUFACTURER ST. Jude Medical ATG, Inc., Maple Grove, MN

REASON The tubeset was not securely held within the handle of the delivery system on some units.

VOLUME OF PRODUCT IN COMMERCE 228 units.

DISTRIBUTION Nationwide and France, Netherlands, Finland, and Australia.

 

PRODUCT Immulite Cat Specific IgE; radioallergosorbent immunological test system.  100 test kit, Id# LKE11 115

CODE Immulite Cat Specific IgE, LKE11 115

RECALLING FIRM/MANUFACTURER Diagnostic Products Corp. Los Angeles, CA

REASON Packaging equipment failure, missing bead component.

VOLUME OF PRODUCT IN COMMERCE 40 kits.

DISTRIBUTION Internationally.

 

PRODUCT AxSYM REA Ethanol Reagent.  Distributed under the following brand: AxSYM  Abbott Laboratories USA North

CODE List No. 03B32-20.

Lot No.                   Exp. Date

71356Q100             7/10/2001

72265Q100             7/22/2001

73456Q100             9/2/2001

73721Q100             10/9/2001

75536Q100             10/26/2001

76487Q100             11/14/2001.

RECALLING FIRM/MANUFACTURER Abbott Health Products, Inc. Barceloneta, Puerto Rico

REASON Failure/inability to obtain a valid calibration curve

VOLUME OF PRODUCT IN COMMERCE 12,776 units.

DISTRIBUTION Internationally.

 

PRODUCT Roche Glucl Cobas Integra Glucose HK Liquid, catalog # 2055651

CODE Lot 624277-01.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Roche Diagnostics Corp., Indianapolis, IN

Manufacturer:  Roche Diagnostics, Mannheim, Germany.

REASON Reduced linearity/does not meet linearity range in directions for use.

VOLUME OF PRODUCT IN COMMERCE 1620 cassettes.

DISTRIBUTION Nationwide and Puerto Rico.

 

PRODUCT LocaLisa IntraCardiac Navigation System, Model Numbers 9670000, 9670025.

CODE BBJ0106OO1, BBJ0107OO2, BBJ0107OO3, BBJ0107OO4, BBJ0107OO6, BBK0106OO1, BBK0107OO2.

RECALLING FIRM/MANUFACTURER Medtronic, Inc. Minneapolis, MN

REASON A read only CD drive was installed in the system in place of a read-write CD drive.

VOLUME OF PRODUCT IN COMMERCE 7 units.

DISTRIBUTION FL, IA and internationally.

 

PRODUCT MedGraphics Pulmonary Function Gas, Reference Gas, 21% O2, Bal N2

CODE Lot number 116617 exp. June 2004 catalog number 536053-009.

RECALLING FIRM/MANUFACTURER Scott Medical Products, Plumsteadville, PA

REASON Concentration of oxygen is less than value stated on label.

VOLUME OF PRODUCT IN COMMERCE 23 cylinders.

DISTRIBUTION Nationwide.

 

PRODUCT Pepsin 1:3000 NF XII Powder, packaged 500g in plastic bottles, 27mg in 2ml plastic vials, and 6,000g bulk bags inside plastic pails

CODE Lot Numbers: 3051B27, 3071B31, 3291B45, 3461B32.

RECALLING FIRM/MANUFACTURER Amresco, Inc. Solon, OH

REASON The product is contaminated with Salmonella bacteria.

VOLUME OF PRODUCT IN COMMERCE 12,046g (26.5 LBS).

DISTRIBUTION MA, IL, NJ and Canada and China.

 

WEEK ENDING FEBRUARY 9

 

PRODUCT Vitros Immunodiagnostics Products - PSA Reagent Pack 100 Test Units.  Responsible firm on the label: "Manufactured by:

Centocor, Diagnostics of PA, Inc. USA, Distributed by Ortho-Clinical Diagnostics, Amersham, United Kingdom.

CODE Cat 188 6704.

Lot Numbers:

130, Exp. 6 August 2001

140, Exp. 29 August 2001

150, Exp. 24 September 2001

160, Exp. 2 November 2001.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Ortho-Clinical Diagnostics Inc., Rochester, NY

Manufacturer:  Fujirebio Diagnostics Inc., Malvern, PA.

REASON Positive bias on patient samples.

VOLUME OF PRODUCT IN COMMERCE Domestic - 544 packs; International - 550 packs.

DISTRIBUTION Nationwide and internationally.

 

PRODUCT Symmetry Aortic Connector System, Model Numbers CAN-4550,

CODE Lots 53739, 54085, 54296, 54330, and 54616.

RECALLING FIRM/MANUFACTURER St. Jude Medical ATG Inc., Maple Grove, MN

REASON The tubeset was not securely held within the handle of the delivery system on some units.

VOLUME OF PRODUCT IN COMMERCE 228 units.

DISTRIBUTION France, Netherlands, Finland and Australia.

 

PRODUCT M/DN Intramedullary Fixation Humeral Nail.  Catalog # 00-2254-255-10,

CODE Lot 20855000.

RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN

REASON Proximal angled hole is oriented in the wrong direction and does not line up when a drill guide is used.

VOLUME OF PRODUCT IN COMMERCE 17.

DISTRIBUTION Nationwide and Australia, Honduras, Japan, Spain and the United Kingdom.

 

PRODUCT Duracon Total Knee Posterior Stabilizer (PS) Tibial Insert with Locking Screw.

CODE Medium Tibial Inserts

  Catalog numbers/sizes

  6632-4-209, 9mm

  6632-4-211, 11mm

  6632-4-213, 13mm

  6632-4-216, 16mm

  6632-4-219, 19mm

  6632-4-222, 22mm

  6632-4-225, 25mm

Large Tibial Inserts

  Catalog Numbers/Sizes

  6632-4-309, 9mm

  6632-4-311, 11mm

  6632-4-313, 13mm

  6632-4-316, 16mm

  6632-4-319, 19mm

  6632-4-322, 22mm

  6632-4-325, 25mm

Extra Large Tibial Inserts

  Catalog Numbers/Sizes

  6632-4-409, 9mm

  6632-4-411, 11mm

  6632-4-413, 13mm

  6632-4-416, 16mm

  6632-4-419, 19mm

  6632-4-422, 22mm

  6632-4-425, 25mm

All lots manufactured from 1993 through 1997.

RECALLING FIRM/MANUFACTURER Howmedica Osteonics Corp., Rutherford, NJ

REASON The polyethylene post of the Duracon PS Tibial Inserts reportedly fracturing.

VOLUME OF PRODUCT IN COMMERCE 11797 units.

DISTRIBUTION Nationwide and internationally.

 

PRODUCT LifeScan brand One Touch Profile Meter, Blood Glucose Meter

CODE All codes/serial numbers.

RECALLING FIRM/MANUFACTURER Lifescan Inc., Milpitas, CA

REASON Some One Touch Profile Meters may develop display problems.

VOLUME OF PRODUCT IN COMMERCE Approx. 3,000,000 units.

DISTRIBUTION Nationwide and internationally.

 

PRODUCT Preface Guiding Sheath

CODE Catalog numbers; 301-803A; 301-803M; 301-803MS; 301-803P; 301-805M.  All lots manufactured since November 1998.

RECALLING FIRM/MANUFACTURER Cordis Webster Inc., Baldwin Park, CA

REASON Unacceptable tip wall thickness variation.

VOLUME OF PRODUCT IN COMMERCE 5,654.

DISTRIBUTION Nationwide and internationally.

 

PRODUCT Toxoplasma IgM Elisa diagnostic kit, Product No. 508-A1(Lots 128H6484, 108H6339), Product No. 508B (Lots #128H6485,

019H6449). This kit is an enzyme-linked immunosorbent assay (ELISA) designed to the presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum ad for presumptive diagnosis of acute, recent, or reactive Toxoplasma gondii infection.

A) Production # 508-A1 Lot 128H6484A    -    ELISA Plate is labeled in part: " *** T 2682 TOXOPLASMA IgM *** 1 Set *** ELISA PLATE *** (12x1x8 wells) *** Storage:        2-8 C *** Lot 128H6484A *** BIOHAZARD *** For In Vitro   Diagnostic Use *** Exp:07/13/2000 *** Prepared for Sigma               *** STIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

Conjugate Anti-Human vial is labeled in part: "*** C 9221 TOXOPLASMA IgM *** 15 mL *** CONJUGATE *** Storage: 2-8 C *** Lot: 128H6484B *** Exp:08/05/2000 *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

High Positive Control vial is labeled in part: "*** C 9221 TOXOPLASMA IgM *** HIGH POSITIVE CONTROL 0.2 mL *** Lot: 128H6484C *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - Low Positive Standard vial is labeled in part: "*** L 2032 *** TOXOPLASMA IgM *** LOW POSTIVE STANDARD 0.4 mL *** CF=0.48 ***

Lot: 128H6484D *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA *."

 

Negative Control vial labeled in part: "*** N 5030 *** TOXOPLASMA IgM *** NEGATIVE CONTROL 0.2 mL *** Lot: 128H6484E ***

Exp:08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS , MO 63178 USA ***."

 

Product #: 508-A1, Lot 108H6339 ELISA Plate is labeled in part: " *** T 2682 TOXOPLASMA IgM *** 1 Set *** ELISA PLATE *** (12x1x8 wells) *** Storage: 2-8 C ** Lot: 108H6339A *** BIOHAZARD *** For In Vitro Diagnostics Use *** Exp: 04/16/2000 *** Prepared for Sigma *** Sigma DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

CONJUGATE Anti-Human vial is labeled in part: "*** C 9221 TOXOPLASMA IgM ** 15mL *** CONJUGATE *** Storage: 2-8 C *** Lot:

        108H6339B *** Exp:05/11/2000 ** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

High Positive Control vial is labeled in part: " *** H 9529 *** TOXOPLASMA IgM *** HIGH POSITIVE CONTROL 0.2 mL *** Lot: 108H6339C *** Exp: 05/11/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS< INC. ST. LOUIS, MO 63178 USA ***."

 

Low Positive Standard vial is labeled in part: "*** L 2032 *** TOXOPLASMA IgM *** LOW POSITIVE STANDARD 0.4 mL *** CF=0.48 *** Lot: 108H6339D *** Exp: 05/11/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. LOUIS, MO 63178 USA*."

 

Negative Control vial labeled in part: "*** N 5030 *** TOXOPLASMA IgM *** NEGATIVE CONTROL 0.2 mL *** Lot: 108H6339E ** Exp:08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

Product #: 508B, Lot 019H6449 ELISA Plate is labeled in part: "*** T 2682 TOXOPLASMS IgM *** 1 Set *** ELISA PLATE *** (12x1x8 wells) *** Storage: 2-8 C *** Lot: 019H6449A *** BIOHAZARD *** For In Vitro Diagnostics Use *** Exp: 7/13/2000 *** Prepared for Sigma  *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

Conjugate Anti-Human vial is labeled in part. "*** C 9221 TOXOPLASMA IgM *** 30mL *** CONJUGATE *** Storage: 2-8 C *** Lot:

        019H6449B *** Exp: 09/02/2000 *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA***."

 

High Positive Control vial is labeled in part: "*** H 9529 ** TOXOPLASMA IgM *** HIGH POSITIVE CONTROL 0.5 mL *** Lot: 019H6449C *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSITCS, INC. ST. LOUIS, MO 63178 USA ***."

 

Low Positive Standard vial is labeled in part: "*** L 2032 *** TOXOPLASMA IgM *** LOW POSITIVE STANDARD 0.5 mL ***CF=0.46 *** Lot: 019H6449D *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

Negative Control vial labeled in part: "*** N 5030 *** TOXOPLASMA IgM *** NEGATIVE CONTROL 0.5 mL *** Lot: 019H6449E ***

        Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSITCS, INC. ST. LOUIS, MO 63178 USA ***."

 

Product #: 508B, Lot 128H6485AELISA Plate is labeled in part: " *** T 2682 TOXOPLASMA IgM *** 1 Set*** ELISA PLATE *** (12x1x8 wells) *** Storage: 2-8        C *** 128H6485A *** BIOHAZARD *** For In Vitro Diagnostics Use *** Exp: 07/13/2000 *** Prepared for Sigma *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

Conjugate Anti-Human vial is labeled in part: "*** C 9221 TOXOPLASMA IgM *** 30mL *** CONJUGATE *** Storage: 2-8 C *** Lot: 128H6485B *** Exp:08/04/2000 *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 64178 USA ***."

 

High Positive Control vial is labeled in part: " *** H 9529 *** TOXOPLASMA IgM *** HIGH POSITIVE CONTROL 0.5 mL *** Lot: 128H6485C *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTIC, INC. ST. LOUIS, MO 63178 USA ***."

 

Low Positive Standard vial is labeled in part: "*** L 2032 *** TOXOPLASMA IgM *** LOW POSTIVE STANDARD 0.5 mL *** CF=0.46 *** Lot: 128H6485D *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C*** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA

 

Negative Control vial labeled in part: "*** N 5030 *** TOXOPLASMA IgM *** NEGATIVE CONTROL 0.5 mL *** Lot: 128H6485E *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***."

 

Product # 8Z8651M, Lot # 8TOXO02819 Primary carton labeled in part: Product NO:8Z8651M *** TOXO *** IgM *** 96 TEST *** THIS KIT CONTAINS: *** ZEUS ELISA *** MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** lot: 8TOXO02918 EXP: 02/29/2000 ***"

 

Top inside flap of primary carton labeled in part: " *** COMPONENT LOT NUMBERS AND EXPIRATION DATES *** Description:        TOXOPLASMA IgM ELISA KIT *** Kit Exp. Date: 02/29/2000 *** Kit Lot No: 8TOXO02918 *** COMPONENT *** LOT NUMBER *** EXP. DATE ***"

 

ELISA Plate labeled in part " *** NO.8652 *** ONE *** TOXO *** ELISA Plate *** 12, 1x8 WELLS *** Reseal for storage of unsealed strips *** For in vitro diagnostics use *** Store at 2 C- 8 C *** Lot: KX728 *** Exp: 04/16/2000 **MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869***"

 

Conjugate Anti-Human IgM labeled in part: "*** No 8653M *** TOXO IgM *** Horseradish Peroxidase Conjugated Anti-Human IgM *** DO NOT DILUTE *** READ TO USE *** 15 mL ***MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** Lot: KX729 *** EXP: 05/11/2000 ***"

 

High Positive Serum Control vial labeled in part:" *** NO 8653-HM *** TOXO IgM *** Human High Positive Serum Control *** 0.2 mL *** MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** Lot: KX732 *** EXP: 05/11/2000 ***"

 

Negative Serum Control vial labeled in part:" *** NO 8655M *** TOXO IgM *** Human Negative Serum Control *** 0.2 mL *** MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** Lot: KX731 *** EXP: 05/11/2000 ***"

 

Human Low Positive Serum Standard vial labeled in part: "*** NO 8654-LM *** TOXO IgM *** Human Low Positive Serum Standard *** 0.4 mL *** MANUFACTURED BY: Zeus Scientific,     Inc. *** Raritan, NJ 08869 *** Lot: KX733 *** CF=0.40 *** EXP: 05/11/2000 ***"

CODE The product number and corresponding lot numbers are as follows:

PRODUCT No. Kit Lot Number         Kit Expires

508-A1                   128H6484                               3/31/2000

508-A1                   108H6339                               3/31/2000

508B                       128H6485                               7/13/2000

508B                       019H6449                               7/13/2000

8663780                  8TOXO02918                        2/19/2000

The lot numbers on the ELISA plate have the suffix "A", Conjugate have a lot number with a suffix "B", high positive standard have a lot number with a suffix "C", low positive standard have a lot number with a suffix "D", Negative control has a lot number with a suffix "E."

RECALLING FIRM/MANUFACTURER Zeus Scientific Inc., Branchburg, NJ

REASON False positives; the positive standard has degraded.

VOLUME OF PRODUCT IN COMMERCE 487 kits.

DISTRIBUTION MO.

 

PRODUCT Guide Wires and Guide Pins (Class I devices, no 510k)

Catalog Numbers      Descriptions

1806-0050S           K-Wire, 3 x 285mm

1806-0085S           Guide Wire (Ball Tip), 3 x 1000mm

3371-1-015           Gamma System Driver Blunt Guide Wire (Ball Tip), 3.0 x 750mm

702336S              A/R Guide Wire (Ball Tip), 3.0 x 1000mm

5235-6-032           Alta System Guide Wire (Smooth Tip), 3.2 x 1000mm

1210-6450S           Gamma System Guide Pin, 3.2 x 450mm

3212-3-010           Gray system GK Guide Wire (Ball Tip), 3.0 x 1000mm

3212-3-125           Gray system GK Guide Wire (Smooth Tip) 2.8 x 600mm

3212-3-030           Gray system GK Guide Wire (Drill Tip), 3.0 x 1000mm

3812-6-250           Humeral system GK Humeral Guide Pin (Ball Tip) 2.0mm

3251-1-232           GK Guide Pin (Ball Tip), 3.2 x 1000mm

3212-3-110           Gray system GK Guide Wire (Ball Tip), 3.0 x 600mm

3212-3-130           Gray system GK Guide Wire (Smooth Tip), 2.0 x 600mm,

CODE All lots manufactured from 1993 to 1997.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Howmedica Osteonics Corp

REASON Possible loss of sterile seal integrity.

VOLUME OF PRODUCT IN COMMERCE 7509 -- domestic; 500 -- international; 4317 - frozen.

DISTRIBUTION Nationwide.

 

PRODUCT All DataCare Systems Software, as follows:

A) DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing

environment; Catalog GD9200.  Sold in the U.S.

B) DataCare Networked Client Computer for DataCare ABG Data Management System for use in a blood gas point of care testing

environment; Catalog GD9201.  Dist. in U.S.

C) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment); Catalog BP9251;

D) DataCare Networked Client Kit for customer that includes manual and software (sent in conjunction with DataCare Networked Client Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252;

E) DataCare Server/Workstation Computer for DataCare POC Software Data Management System for use in a blood gas, glucose and

coagulation point of care testing environment; Catalog GD9200.  Dist. in U.S., Canada and the United Kingdom;

F) DataCare Networked Client Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation

point of care testing environment; Catalog GD9201.  Dist. in U.S., Canada and the United Kingdom;

G) DataCare Networked Client Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation

point of care testing environment; Catalog GD9206.  Dist. U.S., Canada and the United Kingdom;

H) DataCare Power Class Server Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation

point of care testing environment; Catalog GD9207.  Dist. U.S., Canada and the United Kingdom;

I) DataCare Laptop Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9208.  Dist. U.S., Canada and the United Kingdom;

J) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9251.  Dist. U.S., Canada and the United Kingdom;

K) DataCare Networked Client Kit for customer that includes manual and software (sent in conjuction with DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9252.  Dist. U.S., Canada and the United Kingdom;

L) DataCare Server/Workstation Computer for DataCare GM Data Management System for use in a glucose only point of care testing

environment; Catalog GD9202.  Dist. U.S.;

M) DataCare Networked Client Computer for DataCare GM Data Management System for use in a glucose only point of care testing

environment; Catalog GD9209.  Dist. U.S.;

N) DataCare Server Class Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment;

Catalog GD9210.  Dist. U.S.;  

O) DataCare Power Class Server Computer for DataCare GM Data Management System for use in a glucose only point of care testing

environment; Catalog GD9211.  Dist. U.S.; 

P) DataCare Laptop Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212. Dist. U.S.; 

Q) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment); Catalog BP9215. Dist. U.S.; 

R) DataCare Networked Client Kit for customer that includes manual and software for use in conjunction with DataCare Networked Client Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216; Dist. U.S.

CODE All units.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Roche Diagnostics Corp, Indianapolis, IN

Manufacturer:  Roche Diagnostics Corp., Roswell, GA.

REASON Possible sample results mismatch with patient information.

VOLUME OF PRODUCT IN COMMERCE Approx. 450 installations.

DISTRIBUTION Nationwide, Canada and the United Kingdom.

 

PRODUCT LocaLisa IntraCardiac Navigation System, Model Numbers 9670000, 9670025.

CODE BBJ0106OO1, BBJ0107OO2, BBJ0107OO3, BBJ0107OO4, BBJ0107OO6, BBK0106OO1, and BBK0107OO2.

RECALLING FIRM/MANUFACTURER Medtronic Inc., Minneapolis, MN

REASON A read only CD drive was installed in the system in place of a read-write CD drive.

VOLUME OF PRODUCT IN COMMERCE 7 units.

DISTRIBUTION FL and IA, Medtronic, B.V., Kerkrade, Netherlands and Europe.

 

PRODUCT Mammography Film, New CM-H Size 18 x 24 Emulsion Series 6107.

CODE

Catalog #          Size               Item           Lot (Emulsion)#

0136318           (18x24 cm)      29476         6107

0136324           (24x30 cm)      29477         2107.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Konica Medical Imaging, Wayne, NJ

Manufacturer: Konica Corp. Shinjuku-ku, Tokyo. 

REASON Mammography film does not meet speed or sensitivity control limits.

VOLUME OF PRODUCT IN COMMERCE 1906 boxes.

DISTRIBUTION NJ, GA, TX, CA and IL.

 

WEEK ENDING FEBRUARY 16

 

PRODUCT Solar 9500 Physiological ECG monitor

CODE Serial Numbers: C1MU1460G, D1MU1469G, D1MU1470G, D1MU1471G, D1MU1474G, D1MU1475G, D1MU1476G, D1MU1477G, D1MU1478G, D1MU1480G, D1MU1487G, D1MU1489G, D1MU1492G, D1MU1494G, D1MU1498G, D1MU1499G, D1MU1503G  D1MU1506G, D1MU1508G, D1MU1509G, D1MU1510G, D1MU1516G, D1MU1518G, D1MU1519G, D1MU1520G, D1MU1523G, E1MU1525G, E1MU1526G, E1MU1527G, E1MU1529G, E1MU1530G, E1MU1535G, E1MU1538G, E1MU1539G, E1MU1541G, E1MU1544G, E1MU1547G, E1MU1548G, E1MU1564G, F1MU1566G,  F1MU1569G, F1MU1571G, F1MU1572G, F1MU1577G, F1MU1580G, F1MU1583G, F1MU1588G, F1MU1589G, F1MU1591G, F1MU1594G, G1MU1596G, G1MU1597G, G1MU1598G, G1MU1601GMU, G1MU1602GMU, NB1643428, NB1664094, NB1664099, NB1664109, NB1664113, NB1664117, NB1672800, NB1672802, NB1672823, NB1672832, NB1672840, NB1734988, NB1734990, NB1734997, NB1743637,  B1743638, NB1743639, NB1743640 - NB1743666, NB1786821, NB1786822, NB1786826, NB1786827, NB1786828, NB1786832,

NB1786838, and NB1807559.

RECALLING FIRM/MANUFACTURER GE Medical Systems, Information Technologies Milwaukee, WI

REASON The installation of incorrect chips could result in device failure.

VOLUME OF PRODUCT IN COMMERCE 73 monitors.

DISTRIBUTION CO, IA, IL, MS, OH, TN, TX, WI and Belgium,

Denmark, France and the Netherlands.

 

PRODUCT Vitros 950 and 950AT Chemistry Systems Responsible firm on the label: Made in U.S.A. Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY  14626

CODE Vitros 950: s/n less than 09501559, Vitros 950AT: s/n less than 09600129

RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, NY

REASON Positive outliers for Potassium.

VOLUME OF PRODUCT IN COMMERCE VITROS 950 - 1,420; VITROS 950AT - 30

DISTRIBUTION Nationwide.

 

PRODUCT Vitros ECi Immunodiagnostic System

CODE s/n 30000054 thru 30001160.

RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Inc. Rochester, NY

REASON Biased results due to inadequate delivery of reagent fluids to the reaction well.

VOLUME OF PRODUCT IN COMMERCE 1,157

DISTRIBUTION Worldwide.

 

PRODUCT Polarus Broach.  Instrument belongs to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumention.  The broach is reusable and provided non-sterile.

CODE Lot #W03397.

RECALLING FIRM/MANUFACTURER Acumed, Inc., Beaverton, OR

REASON The word “lateral” is marked on the medial side of the broach.

VOLUME OF PRODUCT IN COMMERCE 27

DISTRIBUTION United Kingdom, Finland, Spain and The Netherlands.

 

PRODUCT Datascope's Profile 8 French Intra-Aortic Balloon Catheter.

CODE 0684-00-0297-01, Lot #1095, expiry date 10/17/2003

0684-00-0299-01, Lot #1097, expiry date 10/27/2003

0884-00-3441-01, Lot #1097, expiry date 10/27/2003

0884-00-3441-02, Lot #1097, expiry date 10/27/2003.

RECALLING FIRM/MANUFACTURER Datascope Corp., Cardiac Assist Division Fairfield, NJ

REASON Catheters may have a misalignment in the inner lumen path.

VOLUME OF PRODUCT IN COMMERCE Lot #1095 -- 89 units; Lot #1097 -- 746 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Accu-Chek HQ System, Meter Cradle with Scanner

CODE Catalog numbers 2138026 and 2139260.  All units.

RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN

REASON Patient/sample mismatch.

VOLUME OF PRODUCT IN COMMERCE 5,000.

DISTRIBUTION Nationwide.

 

PRODUCT ADAC brand Pinnacle Radiation Therapy Planning System Radiation Therapy Treatment Software version 5.2g,

CODE Model: 9200-0579A.

RECALLING FIRM/MANUFACTURER ADAC Laboratories, Milpitas, CA

REASON A Software problem that could result in incorrect radiation dosage being applied.

VOLUME OF PRODUCT IN COMMERCE 373 units.

DISTRIBUTION Nationwide and internationally.

 

PRODUCT Troponin I Reagent Pack - for In Vitro Diagnostic Use Only Cat 194 9882, 100 Test Units

Responsible firm on the label:  Ortho-Clinical Diagnostics, Amersham, UK. 

CODE Lot Numbers:

503, Exp. 23 January 2002

504, Exp. 26 January 2002

510, Exp. 16 January 2002

521, Exp. 19 February 2002

531, Exp. 25 March 2002.

RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Inc. Rochester

REASON False positive results on some serum & EDTA plasma samples.

VOLUME OF PRODUCT IN COMMERCE 6,436.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT CryoValve Allograft

CODE Model No. PV00 - Serial Number 7162707.

RECALLING FIRM/MANUFACTURER Cryolife, Inc. Kennesaw, GA

REASON Donor kidney was positive for cancer.

VOLUME OF PRODUCT IN COMMERCE 1 unit.

DISTRIBUTION MN.

 

PRODUCT Digene brand, Hybrid Capture (tm) System Automated Plate Washer I

CODE Serial numbers 232928, 232947, 232907, 232960, 232903, 232959, 232920, 232905 and 232904

RECALLING FIRM/MANUFACTURER Recalling Firm:  Digene Corp. Gaithersburg, MD

Manufacturer:  TriContinent Grass Valley, CA

REASON IVD microwell plate washer malfunctioned.

VOLUME OF PRODUCT IN COMMERCE 9

DISTRIBUTION CA, NY, OH, TX, VA and Germany.

 

PRODUCT Soft Cell (tm), PVA Foam Surgical Spears, Quantity: 10 Spears per package, 150 Spears per case/carton.

CODE All Lots, Manufacturing Date Sept 2001; Expiry date October 2004.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Oasis Medical, Inc., Glendora, CA

Manufacturer:  M-Pact Corporation Eudora, KS.

REASON Increase in reports of kerratitis attributed to PVA Foam Spears from lot 1220C.

VOLUME OF PRODUCT IN COMMERCE 3,247.

DISTRIBUTION Nationwide and Internationally.

 

WEEK ENDING FEBRUARY 23

 

PRODUCT Solar 9500 Physiological ECG monitor

CODE Serial Numbers: C1MU1460G, D1MU1469G, D1MU1470G, D1MU1471G, D1MU1474G, D1MU1475G, D1MU1476G, D1MU1477G, D1MU1478G, D1MU1480G, D1MU1487G, D1MU1489G, D1MU1492G, D1MU1494G, D1MU1498G, D1MU1499G, D1MU1503G, D1MU1506G, D1MU1508G, D1MU1509G, D1MU1510G, D1MU1516G, D1MU1518G, D1MU1519G, D1MU1520G, D1MU1523G, E1MU1525G, E1MU1526G, E1MU1527G, E1MU1529G, E1MU1530G, E1MU1535G, E1MU1538G, E1MU1539G, E1MU1541G, E1MU1544G, E1MU1547G, E1MU1548G, E1MU1564G, F1MU1566G, F1MU1569G, F1MU1571G, F1MU1572G, F1MU1577G, F1MU1580G, F1MU1583G, F1MU1588G, F1MU1589G, F1MU1591G, F1MU1594G, G1MU1596G, G1MU1597G, G1MU1598G, G1MU1601GMU, G1MU1602GMU, NB1643428, NB1664094, NB1664099, NB1664109, NB1664113, NB1664117, NB1672800, NB1672802, NB1672823, NB1672832, NB1672840, NB1734988, NB1734990, NB1734997, NB1743637, B1743638,  NB1743639, NB1743640, NB1743666, NB1786821, NB1786822, NB1786826, NB1786827, NB1786828, NB1786832,

NB1786838, NB1807559.

RECALLING FIRM/MANUFACTURER GE Medical Systems, Information Technologies Milwaukee, WI

REASON The installation of incorrect chips could result in device failure.

VOLUME OF PRODUCT IN COMMERCE 73 Monitors.

DISTRIBUTION CO, IA, IL, MS, OH, TN, TX, WI and Belgium, Denmark, France and the Netherlands.