AUGUST 2000
WEEK ENDING AUGUST 11

PRODUCT Elecsys HGC STAT Immunoassay, a pregnancy test kit for use on Roche Elecsys analyzers
CODE Catalog #1731289, All Lots (Lot No. 198859, EXP 02/28/01; 151150, EXP 11/30/01).
MANUFACTURER Roche Diagnostics GmbH, Penzburg, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON There is an incidence of false elevation in pregnancy test results for the above method that is not related to HAMA (human anti-mouse antibody) interference. This effect manifests as a repeatable positive result that cannot be confirmed by alternative methodologies.

PRODUCT Access brand immunoassay Reagent Packs, in-vitro diagnostic medical devices:
a) Beckman Coulter Access Troponin I brand Immunoassay System Reagent Pack;
b) Beckman Coulter Access CEA brand Immunoassay system reagent pack;
c) Beckman Coulter Access PSA brand Immunoassay system reagent pack;
d) Beckman Coulter Access Rubella IgG brand Immunoassay system reagent pack;
e) Beckman Coulter Access Toxoplasma IgM Brand Immunoassay system reagent pack.
CODE a) Catalog #33320, Lot #993831 EXP 03/01/00, Catalog #993833 EXP 04/15/00;
b) Catalog #33200, Lot #997617 EXP 2/15/00 (Intíl only);
c) Catalog #33220, Lot #904753 EXP 01/01/00, Catalog #904762 EXP 01/01/00);
d) Catalog #34430, Lot #990232 EXP 07/15/00, Catalog #990233 EXP 10/01/00;
e) Catalog #34460, Lot #990532 EXP 05/01/00.
MANUFACTURER Sanofi Diagnostics Pasteur, Coquette, France.
RECALLED BY Beckman Coulter, Inc., Brea, California
DISTRIBUTION Nationwide and international.
QUANTITY
a) 5,624 of lot #993831 and 5,686 of lot 993833
b) 222 of lot 97617
c) 1,210 of lot 904753 and 218 of lot 904762
d) 5,102 of lot 990232, and 1,972 of lot 990233
e) 1,636 of lot 990532 were distributed.
REASON The above reagent packs may have been improperly filled or contain an incorrect reagent component.

PRODUCT Chiron Vision SoFlex Foldable UV-Absorbing Posterior Chamber Silicone Intraocular Lens, Model L151U.
CODE Lot #2042191.
MANUFACTURER Baush & Lomb Surgical, Claremont, California.
RECALLED BY Baush & Lomb Surgical, Irvine, California
DISTRIBUTION Arkansas and Tennessee.
QUANTITY 25 lenses were released.
REASON The lenses were polished using an incorrectly prepared polishing mixture that resulted in the lens causing a cloudy visual acuity for the patient.

WEEK ENDING AUGUST 18

PRODUCT Abbott Multiconstituent Calibrator, List #IE65-01, for in-vitro diagnostic use.
CODE Lot #55765M100 EXP 01/10/01.
MANUFACTURER MAS, Inc., Camarillo, California.
RECALLED BY Abbott Laboratories, Inc., South Pasadena, California
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,621 kits were distributed.
REASON A shift in control values on Creatinine assay.

PRODUCT Abbott A-GENT Uric Acid Standard Kit, for in-vitro diagnostic use.
CODE Catalog #06008-02, Lot #61015HWOO EXP 11/30/00 and Lot #61070H00 EXP 11/30/00.
MANUFACTURER CASCO/NERL Company, East Providence, Rhode Island.
RECALLED BY Abbott Laboratories, South Pasadena, California
DISTRIBUTION Nationwide, Germany, St. Martin, Mexico, Venezuela, Taiwan, Dominican Republic, Colombia, Jamaica, San Salvador, Argentina, Hong Kong, Italy, Korea, Singapore, Japan, Canada, Bahamas, Brazil, West Indies, Honduras, Cayman Islands, Paraguay, Uruguay.
QUANTITY 404 kits were distributed.
REASON The standard labeled 6mg/dL is recovering at approximately 5mg/dL. Use of these Standards on the spectrum instrument will result in a calibration failure.

WEEK ENDING AUGUST 25

PRODUCT Laser Pointers, wide range in academic, industry and consumer use: a) Model DPGL; b) Model DPIR
CODE a) DPGL Series 1000, 2000, 3000, 3000F;b) DPIR Series 1000 and 2000, and Polaris Laser Pointer.
MANUFACTURER Casix, Inc., Chatsworth, California.
DISTRIBUTION Nationwide.
QUANTITY 1,280 units were distributed.
REASON Noncompliance with performance with the Federal laser product performance standard, 21 CFR 1040.10 in that products lack beam attenuators, emission indicators, remote interlock connectors, and required labeling.

PRODUCT Diode-pumped solid state micro lasers, for various uses including academia and industry applications.
CODE Model Numbers 43XX, 45XX, 46XX.
MANUFACTURER JDS Uniphase, Manteca, California.
DISTRIBUTION Nationwide.
QUANTITY 40 units were distributed.
REASON The laser product failed to comply with the Federal laser product performance standard, 21 CFR 1040.10 in that the following deficiencies: beam attenuator, key control, emission indicator, remote interlock connector and labeling.

PRODUCT a) Baxter Thermo(tm) Stat Hypothermia Warming Mitt/Seal (Hand Model), Catalogue No. 10-1005/1T0310; b) Aquarius Medical Corporation Thermal Rescue Hypothermia Warming Mitt and Seal (Hand Model), Catalog No. 06-0003/1T0311; c) Aquarius Medical Corporation Thermal Rescue Hypothermia Warming Mitt and Seal (Hand Model), Catalogue No. TR-04004/ETR-04004.
CODE All lot numbers.
MANUFACTURER Aquarius Medical Corporation, Scottsdale, Arizona.
DISTRIBUTION Alaska, Arizona, California, Colorado, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, Montana, New York, Oregon, Pennsylvania, Texas, District of Columbia, Canada, Norway.
QUANTITY Approximately 2,440 units were distributed.
REASON Water evaporates through the polyvinyl chloride bag over extended periods of storage, leading to a higher salt concentration with increase in mitt temperature, with possible thermal injury to the patient.

PRODUCT Bear 1000 Ventilator, an adult/pediatric ventilator intended to provide continuous mechanical ventilation of adult and pediatric patients: a) Catalog #50-08550; b) 50-08555;c) 50-08560; d) 50-08570
CODE Various serial numbers in the range 11008756 to 11008959, shipped from 1/17/00 to 4/28/00.
MANUFACTURER Bear Medical Systems, Palm Spring, California.
DISTRIBUTION Alabama, California, Florida, Louisiana, Massachusetts, Missouri, New York, Pennsylvania, Texas, Washington state, West Virginia, Algeria, Brazil, Canada, China, Costa Rica, Greece, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Korea, Mexico, The Netherlands, Russia, Saudi Arabia, Turkey, The United Arab Emirates.
QUANTITY 185 ventilators are in distribution. In addition 24 EPI circuit board service replacements were distributed.
REASON There is possible corrosion of the mechanical relay that activates the loss of power alarm.

PRODUCT Fukuda Denshi, Model DS-5300 Patient Monitor, used to monitor one or more of the following on an individual patient: ECG, respiration, non-invasive and/or invasive blood pressures, temperature, pulse oximetry and cardiac output.
CODE Serial number range: 27120281 through 29061471 (non-consecutive).
MANUFACTURER Fukuda Denshi Company, Ltd., Tokyo, Japan.
RECALLED BY Fukuda Denshi USA, Inc., Redmond, Washington
DISTRIBUTION Florida, Pennsylvania, California, Arizona, Ohio, New Hampshire, Kentucky, and Canada.
QUANTITY 96 units were distributed.
REASON Power supply sub-assembly may fail causing the DS 5300 Patient Monitor to become inoperable.

PRODUCT Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, intended for cemented or non-cemented use in adults undergoing primary surgery for rehabilitating hips: a) Zimmer Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, Standard, 28 mm I.D., for use with 60 mm O.D. Shell, Catalog No. 00-6305-060-28; b) Zimmer Trilogy Acetabular System Longevity Crosslinked Polyethylene Liner, 7mm Ofset, 32 mm I.D., for use with 70 mm O.D. Shell, Catalog No. 00-6341-070-3.
CODE a) Lot No. 67465500; b) Lot No. 67257700.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
DISTRIBUTION California, Illinois, Kansas, Louisiana, Maryland, Massachusetts, Minnesota, Nebraska, Oregon, Pennsylvania, Texas, Virginia, Washington state, Wisconsin, Australia.
QUANTITY 27 units were distributed.
REASON 70 mm liners are inside a 60 mm package.

PRODUCT Merifluor VZV IgM IFA/IFT, a rapid imunofluorescence test kit for the detection of IgM antibodies to varicella-zoster virus (VZV) in human serum
CODE Lot #VZ150.001, Catalog #VZ150/4878031.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Florida, Illinois, Nevada, New York, Oklahoma.
QUANTITY 38 units were distributed.
REASON The VZV IgM IFA/IFT test kits are incorrectly labeled as EBV IgM IFA/IFT kits.

PRODUCT Cephalothin Susceptibility Test Disks, KF 30.
CODE Catalog #33860, Lot #226063 EXP 11/02.
MANUFACTURER Oxoid Ltd., United Kingdom.
RECALLED BY Remel, Inc., Lenexa, Kansas
DISTRIBUTION Nationwide.
QUANTITY 99/5/50 disk cartridge boxes were distributed.
REASON Product was labeled as Cephalothin Susceptibility Test Disks but contained Vancomycin Susceptibility Test Disks.

PRODUCT Richard Allan Dispos-a-Ture Needles, Eyed Surgical Needles, Mayo Catgut 1/2 Circle Taper Point (Heavy), a disposable suturing needle.
CODE Product #216705, Lot #2004-08-06.
RECALLED BY Aspen Surgical Products, Inc., Grand Rapids, Michigan
DISTRIBUTION Nationwide.
QUANTITY 60 boxes (72 pounces/2 needles per pouch) were distributed.
REASON The outer boxes are labeled to contain, and do contain, product #216705, the individual pouches within the boxes are labeled as product 216706. The two needles are different sizes.

PRODUCT Architect i 2000 System.
CODE All units, all software versions.
MANUFACTURER Abbott Laboratories, Inc., Irving, Texas.
RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois
DISTRIBUTION Nationwide, Puerto Rico, Korea, Mexico, Canada, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Australia, New Zealand.
QUANTITY 603 units were distributed.
REASON System allows running of samples while the automatic flushing/cleaning occurs.