DECEMBER 2000

WEEK ENDING DECEMBER 1

PRODUCT Mobile Digital Imaging Systems, C-Arm fluoroscopic x-rays: a) Series 7700; b) Compact 7700.
CODE None.
MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, Utah.
DISTRIBUTION Nationwide and international.
QUANTITY 218 units were distributed.
REASON The diagnostic x-ray devices were found defective under 21 CFR 1003.10 and failed to comply with the performance standard in 21 CFR 1020.32(c). The defect occurs as a result of the emission of electronic product radiation that is unnecessary to the accomplishment of its primary purpose and which creates a risk of injury to the operator and patient. The system also failed to meet the fluoroscopic performance standard 21 CFR 1020.32(c) "X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure".

PRODUCT Series 9800 Mobile Digital Imaging Systems, C-Arm Fluoroscopic x-rays.
CODE Series 9800.
MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, Utah.
DISTRIBUTION Nationwide and international.
QUANTITY 795 units were distributed.
REASON The diagnostic x-ray devices were found defective under 21 CFR 1003.10. The defect occurs as a result of the emission of electronic product radiation that is unnecessary to the accomplishment of its primary purpose and which creates a risk of injury to the operator and patient.

PRODUCT Vitros Calibration Diskette DRV 5285, for use with Vitros 250 and 950 Chemistry Systems, when used in conjunction with Generation 48 Digoxin Slides: a) Catalog #825 1878 Vitros 250 Chemistry System; b) Catalog #871 6607 Vitros 950 Chemistry System.
CODE Data Release Version 5825.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York.
DISTRIBUTION Nationwide, England, France, Germany, Italy.
QUANTITY 1,643 diskettes, affecting over 1,902 Digoxin Gen 48 packs.
REASON The Vitros Calibration Diskette DRV 5285 contained revised parameters that affected the time during which readings were taken by the instrument to calculate reaction rates. This resulted in a shift in digoxin predicted concentration. For customers who received Digoxin GEN 48 Slides and calibrated using an earlier release of the calibration diskette, loading of DRV 5285 without recalibration of Digoxin GEN 48
slides resulted in a negative shift in digoxin results by approximately 1.5 ng/ml.

PRODUCT Steri-Oss brand HL Cylindrical Implants (Endosseous Implants), TPS Coated, 3.25D by14mm, Catalog #3214TPS, device that are surgically placed in the upper or lower jaw to provide support for a prosthetic device, such as artificial teeth and to restore the patients chewing function.
CODE Lot #993719.
MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California.
DISTRIBUTION Arizona, California, Connecticut, Georgia, Kentucky, Massachusetts, New York, Oregon, Texas, Israel, Japan.
QUANTITY 59 units were distributed.
REASON The inner vial label and the vial cap were mislabeled as 12 mm and not 14 mm.

PRODUCT META Pulse Generators.
CODE Model 1256.
MANUFACTURER Teletronics Pacing Systems, Miami Lakes, Florida.
RECALLED BY St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California
DISTRIBUTION Nationwide and international.
QUANTITY 1,848 were implanted.
REASON These devices have shown an increased risk of failure of the pacer processing integrated circuits (IC) that controls the pulse generator. This failure is most commonly characterized by sensing or output anomalies, including the possibility of no output. Extensive analysis has shown that the IC failure is due to electrostatic discharge (ESD) during manufacturing.

PRODUCT GemStar Ambulatory PCA Infusion Pump.
CODE List #13000.
MANUFACTURER Abbott Laboratories, San Diego, California.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 500 units were distributed.
REASON The devices have a dimensional problem in the latch retaining pin for the battery door that can work its way out of the door and then the door cannot be closed.

PRODUCT Accu-Chek Voicemate System, Catalog #2030802, designed for testing glucose in whole blood by visually impaired persons with diabetes.
CODE Lot #119164 and serial number on meter 7674342975.
MANUFACTURER SCI Systems, Inc., Huntsville, Alabama.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY 200 units were distributed.
REASON The Advantage blood glucose meter placed in one system reports results in mmol/L instead of mg/Dl, which may result in an 18-fold difference in the numbers reported out to the patient over the voice readout of the device.

PRODUCT Esprit Ventilator with 10.4-inch Display, color capable.
CODE Various serial numbers.
MANUFACTURER Respironics, Inc., Vista, California.
DISTRIBUTION Nationwide and Japan.
QUANTITY 53 units were distributed.
REASON There is a design deficiency and the backlight inverter PCB needs to be insulated.

PRODUCT Belisle brand Advanced Facial Muscular Therapy, an electrical muscle stimulator system.
CODE All units.
MANUFACTURER Belisle Systems, Inc., Clearwater, Florida.
DISTRIBUTION Texas, New York, California, Kansas, Oklahoma, Georgia, Virginia, Oklahoma, Florida, North Dakota, Louisiana.
QUANTITY 30 units.
REASON Device was marketed without a 510(k) or PMA.

PRODUCT a) Ventrix(r) brand of Ventricular Tunneling Pressure Monitoring Kit, Model NL950-V; b) Complete Ventricular Tunneling Kit, Model #NL950-C. Both products are used to monitor intracranial pressure and drain cerebral spinal fluid.
CODE Lot Numbers: a) 020400; b) VC1040 and VC1041.
MANUFACTURER Integra Neurosciences, San Deigo, California.
DISTRIBUTION Alabama, Arkansas, California, Illinois, Massachusetts, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Venezuela.
QUANTITY 84 units were distributed.
REASON Some kits were packaged with an incorrect trocar/sheath assembly. The kits were supposed to contain 9-10 French size, but were mistakenly packaged with 4-6 French size.

PRODUCT Roche Control Serum N (Human), Catalog #0737119, intended as an assayed quality control material to monitor the accuracy and precision at normal concentration levels in quantitative clinical chemistry assays.
CODE Lot #U0434 EXP 1/31/02.
MANUFACTURER Roche Diagnostics Corporation, Indianapolis, Indiana.
DISTRIBUTION Nationwide.
QUANTITY 750 kits with 20 vials each were distributed.
REASON The normal control show a significant decrease in recovery of Direct Bilirubin. The Direct Bilirubin recovery shows bottle-to-bottle inconsistencies within the affected lot.

PRODUCT Roche Creatinine Enzymatic Reagent, COBAS Integra 400 and 700 Analyzer Operators, Catalog #0763144, reagent intended for use on the COBAS Integra analyzer for the kinetic quantitative determination of creatinine concentration in serum, plasma or urine.
CODE All lot numbers.
MANUFACTURER Roche Diagnostics, Mannheim, Germany.
RECALLED BY Roche Diagnostics, Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY 2,010 units were distributed.
REASON Device may give falsely negative results due to hemoglobin interference. The firm’s medical expert determined that this negative interference can be clinically significant, especially in neonates and children because their creatinine levels are lower in general.

PRODUCT Elecys Estradiol Assay, Catalog #1776002, an in-vitro quantitative determination of estradiol in human serum and plasma.
CODE Lot #199871.
MANUFACTURER Roche Diagnostics, GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY 2,636 kits were distributed.
REASON A shift in recovery was identified for this lot in comparison to the previous lot manufactured. This shift primarily affects samples from males, post menopausal women and IVF patient.

PRODUCT Tina-Quant CRP, for the quantitative measure of C-reactive protein (CRP) in serum and plasma on automated clinical chemistry analyzers: a) Catalog #1551922; b) Catalog #1299859.
CODE All lot numbers.
MANUFACTURER Nissui Pharmaceutical Company, Ltd., Tokyo, Japan.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana (distributor)
DISTRIBUTION Nationwide and Canada.
QUANTITY 3,042 kits were distributed.
REASON Neonatal specimens may initially produce falsely elevated CRP results.

WEEK ENDING DECEMBER 8

PRODUCT AMK Single Step Patella Replacement Basket Instrument (26 mm), Catalog #2500-29-000, an orthopaedic manual surgical instrument intended to be used to cut or shape the patella bone to allow placement of the AMK patella prosthesis, a component of the AMK total knee replacement system.
CODE Lot #U31EF1000.
MANUFACTURER DePuy Orthopaedics, Inc., Warsaw, Indiana.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit.
REASON The device was incorrectly labeled as sterile when it was not properly sterilized.

PRODUCT Rapid Form Vacuum Immobilizer: a) Rapid Form Vacuum Immobilizer 2-piece set, stock #013490 containing 2 splints and 1 pump per set; b) Rapid Form Vacuum Immobilizer 3-piece set, stock #013463 containing 3 splints and 1 pump per set; c) Rapid Form Pump item #013467.
CODE a) Lot LLF246 and LLG320; b) Lot LLF246; c) None.
MANUFACTURER Cramer products, Inc., Gardner, Kansas.
DISTRIBUTION Nationwide.
QUANTITY a) 321 2-piece sets; b) 40 3-piece sets; c) 22 replacement pumps were distributed.
REASON Some incorrect pumps were inadvertently included in splint kits or sent out as replacement pumps.

PRODUCT Roche Creatinine Mira, Catalog #3033414, intended for use on the COBAS MIRA analyzer for the kinetic quantitative determination of creatinine in serum or urine.
CODE Lot #A12071 EXP 9/30/02.
MANUFACTURER Raichem, Division of Hemagen, San Diego, California.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY 2550 units.
REASON 1. The package insert, contained in the kit, was printed with an incorrect reagent volume for COBAS MIRA analyzers using software Version 8735.
2. The device may produce falsely elevated creatinines dues to elevated trigliycerides in the serum samples.

PRODUCT a) Vitros 950 Chemistry System; b) Vitros 950AT Chemistry System.
CODE a) Serial Number less than 09501559; b) Serial Number less than 09600129.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York.
DISTRIBUTION Nationwide and international.
QUANTITY a) 1,420; b) 30 units were distributed.
REASON An atypical pattern in relationship between slide millivold used to calculate a predicted concentration and the millivolt reading used to assess the slide impedance.

PRODUCT Immunosimplicity brand Is anti-ds DNA Test Kit (ONLY the Positive control, lot #60600 is under recall, the kit cannot be used without the positive control), Catalog #720700, an in-vitro diagnostic reagent kit.
CODE Lot #60600, EXP 6/01.Ortho-Clinical Diagnostics, Inc., Rochester, New York.
MANUFACTURER Diamedix Corporation, Miami, Florida.
DISTRIBUTION Tennessee, Florida, Pennsylvania, Virginia, California, Ohio, Missouri, Georgia, Hawaii, Illinois, Costa Rica, Italy.
QUANTITY 137 units were distributed.
REASON Failure of the Positive Control from this lot number kit, to recover within its assigned labeled range.

PRODUCT Roche COBAS Integra Analyzer Operators: a) Cobas Integra 400, Catalog #1045199;
b) COBAS Integra 700, Catalog #1044826; c) COBAS Integra 700, Catalog #1046926.
CODE All serial numbers.
MANUFACTURER Tegimenta AG, Roche Diagnostics Instrument Center, Rotkreuz, Switzerand.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY Approximately 399 analyzers.
REASON Device reagent cassettes previously used on a Cobas Integra analyzer can be interchanged on another Cobas Integra analyzer and that analyzer will treat the used cassette as a new cassette. Under such circumstances the instrument could sample the reagent at the wrong level leading to erroneous results, and could incorrectly reconstitute and/or dispense reagents.

PRODUCT Vascular prostheses: (a) C.R. Bard's Impra Flex(tm) Grafts with small beading; (b) Distaflo(tm) Bypass Grafts.
CODE a) Catalog Nos. F1006TWS, F3006TWSC, F310086TWS, F310086TWSC, F5006S, F5006SC, F5006TWS, F5006TWSC, F5008S, F5008TWS, F5008TWSC, F6006TWS, F6006TWSC, F7004TWS, F7005TWS, F7005TWSC, F7006S, F7006SC, F7006TWS, F7006TWSC, F7007TWS, F7007TWSC, F7008S, F7008SC, F7008TWS, F7008TWSC, F70N75TSC, F70N75TWS, F70T7-4S, F70T74TSC, F70T74TWS, F70T8-5S, F70T85TWS, F8006S, F8006SC, F8006TWS, F8006TWSC, F8007TWS, F8007TWSC, F8008S, F8008SC, F8008TWS, F8008TWSC.
b) Catalog Nos. DF5006SC, DF5007SC, DF6006SC, DF6007SC, DF7006SC, DF5007SC, DF8006SC, DF5007SC.
MANUFACTURER Impra, Inc., Tempe, Arizona.
DISTRIBUTION Canada, New Zealand, Korea, Brazil, Australia, Peru, Japan, Belgium.
QUANTITY 4,270 units were distributed.
REASON The United Kingdom (UK) required the firm to provide better instructions for use to caution the physicians when removing the beading. The UK required the firm to perform a market withdrawal to resolve this problem.

PRODUCT Olympus EVIS-Endoscopic Video Image and Data Systems for examination of the gastrointestinal tract and colon:
a) Olympus Gastrointestinal Fiberscope GIF-2T20;
b) Olympus Gastrointestinal Videoscope GIF-2T100.
CODE a) Olympus Gastrointestinal Fiberscope Model GIF type 2T20 (GIF-2T20), Reprocessing Manual Part Number GR2180. Serial Numbers of affected endoscopes: 2811017, 2811025, 2811028, 2811031, 2811034, 2811035.
b) Olympus Gastrointestinal Videoscope Model GIF type 2T100 (GIF-2T100), Reprocessing Manual Part Number GR2180. Serial numbers of affected endoscopes: 2861291-2861298, 2861300-2861304, 2861306-2861314, 2861316-2861337, 2861339-2861341, 2861344-2861356, 2861358-2861363, 2861365-2861379, 2861383-2861384, 2861386-2861396, 2861398-2861405, 2961406, 2961408-2961423, 2961425-2961426, 2961429-2961431, 2961433-2961437, 2961440-2961458, 2961460- 2961462, 2961464, 2961466-2961470, 2961472-2961492, 2961495-2961500, 2961502-2961516, 2961519.
MANUFACTURER Olympus Opto-Electronics, Ltd. -Aizu Factory, Moden-machi, Fukushima-Ken Japan.
RECALLED BY Olympus America, Inc., Melville, New York
DISTRIBUTION a) Alabama, Rhode Island, Louisiana, Hawaii, Chile, Peru;b) Nationwide and international.
QUANTITY a) 6 units; b) 198 units were distributed.
REASON The labeling instructions for reprocessing both the two suction channel openings as well as the suction switchover lever do not provide enough detailed information regarding reprocessing of this feature and accessory.

WEEK ENDING DECEMBER 15

PRODUCT Sterichek Total Chlorine Reagent Strips, 100-test strips, Product #811904, designed to measure low levels of total chlorine in feed water used to prepare solutions for kidney dialysis.
CODE Product is sold both as a part of a kit and as a single product. Kit lot numbers: 001069, 002069, and 003069. Kits expire 5/01. Bottle lots 002040, 004040, and 003040.
MANUFACTURER Environmental Test Systems, Elkhart, Indiana.
DISTRIBUTION Nationwide and Japan.
QUANTITY Approximately 1,025 bottles.
REASON The test strips which are intended to measure very low chlorine levels in water used for dialysis are ineffective when used to measure high levels of chlorine.

PRODUCT Model SmoothLASE Alexandrite Laser System, used in dermatology.
CODE Undetermined.
MANUFACTURER Leisegang Medical, Inc., Boca Raton, Florida.
DISTRIBUTION Nationwide.
QUANTITY 9 units were distributed.
REASON Device failed to comply with 21 CFR 1010.2, 1040.10(g), 1040.10(h), and 1040.11(a) in that the product lacked certain required labels and operator's manual lacked calibration procedures and labels.

PRODUCT Omnifit Normalized Hip Stem, for use in bipolar and total hip arthroplasty in either a cemented or cementless : a) Omnifit Normalized Hip Stem (Collarless), Catalog No. 6033-0625; b) Omnifit Normalized Hip Stem (Collared), Catalog No. 6034-0625.
CODE a) Lot Code S00L303; b) Lot Code S00L269.
MANUFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey.
DISTRIBUTION California, Florida, Germany, Korea, United Kingdom, Canada, Peru.
QUANTITY 22 units were distributed.
REASON Device was incorrectly labeled as sterile when it was not properly sterilized.

PRODUCT VIP Gold Ventilator; b) VIP Sterling Ventilator.
CODE a) Catalog/Part #15653; b) Catalog/Part #15654.
MANUFACTURER Bird Products Corporation, Palm Springs, California.
DISTRIBUTION Nationwide and international.
QUANTITY 298 units were distributed.
REASON There is a failure to cycle and to alarm during deliberate disconnect.

PRODUCT Electronic Video Colonoscope, a gastrointestinal video system: a) Model EC-200LR, for the lower gastrointestinal tracts; b) Model No. 200LT, allows examination and treatment from rectum to cecum.
CODE Serial Numbers: a) 4Cl6lDOO3, 2Cl6lDll8, 4Cl6lDOOl, 2Cl6lDll2, 2Cl6lDO96, 2Cl6lDlO3, 2Cl6lDlO6, 2Cl6lDlll, 2Cl6lDO97, 2CI61DO98, 2Cl6lDO99, 2Cl6lDll3, 4CI61DO05
b) 4C214DO16, 3C214DO35, 4C214DO06, 4C214DO20, 4C214DO03, 3C214DO27, 4C214DO29, 4C214DO13, 4C214DO09, 4C214DO10, 4C214DO11, 4C214DO08, 4C214DO27, 4C214DO30, 4C214DO04, 4C214DO21, 4C214DO22, 4C214DO26, 4C214DO07, 4C214DO25, 4C214DO02, 4C214DO12, 4C214DO01.
MANUFACTURER Fuji PhotoOptical Company, Ltd., Omiya City, Saitama, Japan.
RECALLED BY Fujinon, Inc., Wayne, New Jersey
DISTRIBUTION Nationwide and Canada.
QUANTITY 36 units.
REASON The video colnonoscope bending sections cannot be properly manipulated.

PRODUCT Vitros C-Reactive Protein (CRP) Slides GEN 18, quantitatively measure C-reactive protein concentration in serum and plasma.
CODE 3718-0132-0111 EXP 9/1/99.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York.
DISTRIBUTION Germany and Sweden.
QUANTITY 291 packs were distributed.
REASON Slides contained cartridges from two different generations that were mixed.

PRODUCT Immulite brand of CMV IgG Test Kit, Model L2KCV2, an in-vitro diagnostic device.
CODE Lot #102A.
MANUFACTURER Diagnostic Products Corporation, Los Angeles, California.
DISTRIBUTION Kansas, New Jersey, India, The Netherlands.
QUANTITY 7 kits were distributed.
REASON The barcode used to label the adjustor kit component had an error that caused the system to reject it. The printing error prevents the barcode from being read and the instruments will not process the assay and patient results will not be obtained.

PRODUCT ACN Biopsy Needle, Part #(model) ACN1410MF, used for obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast and various other soft tissue lesions.
CODE PART NUMBER ACN1410MF and the following lot numbers: 01101469, 01101470, 01101471, 01221644, 01231645, 01241646, 01241647, 01241648, 01261800, 01291801, 01381715, 01381737, 01391736, 01441738, 01581917, 01581961, 01602025, 01612157, 01682158, 01882602, 01922675, 01952765, 02002809, 02022810, 02032811, 02062812, 02203477, 02283673, 02303674, 02343877, 02373933, 02373934, 02494027, 02564117, 02624228, 02634227 and 02664354.
MANUFACTURER Medical Device Technologies, Inc., Gainesville, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 2,374 units were distributed.
REASON Needle did not operate smoothly in gun, potentially affecting QUANTITY of sample.

PRODUCT a) Osteonics C-Taper Head 26 mm, + 0, Catalog No. 06-2600; b) Osteonics C-Taper Head 26 mm, +10, Catalog No. 06-2610, indicated for use of the Osteonics Ion Implanted Femoral Bearing Series as part of a universal hip replacement.
CODE a) Lot No. 56629202 b) Lot No. 56584201.
MANUFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey.
DISTRIBUTION Nationwide and Australia.
QUANTITY 32 units were distributed.
REASON Packages labeled Catalog No. 06-2600 (Osteonics C-Taper Head 26 mm, + 0) contained Catalog No. 06-2610 (Osteonics C-Taper Head 26 mm, +10), and vice versa.

PRODUCT Immulite 2000 PAP IVD Test Kit, for the chemiluminescent enzyme immunometric assay for the quantitative measurement of prostatic acid phosphatase.
CODE Lot # L2KPA2 6103 EXP 11/30/00.
MANUFACTURER Diagnostic Products Corporation, Los Angeles, California.
DISTRIBUTION Arizona, California, Missouri, New Jersey, Texas, Utah, Australia, Brazil, Germany, Italy, Spain, Sweden, Switzerland, Turkey, United Kingdom.
QUANTITY 17 kits were distributed.
REASON The second full reagent wedge of the same lot on the system will erroneously be recognized as being empty, no further processing will take place and test results will not be possible to obtain.

PRODUCT ROCHE c.f.a.s. Calibrator for automated systems, Catalog No. 759350, used for calibration of Roche methods on clinical chemistry analyzers.
CODE Lot Nos. 199608 through 199611, 199845 through 199848.
MANUFACTURER Roche Diagnostics, GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corp., Indianapolis, Indiana
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Approximately 10,000 kits were distributed.
REASON The setpoints of the master lot and customer lot produce small bias that may produce calcium results too high.

PRODUCT Abbott Multiconstituent Calibrator, for use with the ALCYON Analyzer and AEROSET System for the calibration of albumin, calcium, cholesterol, creatinine, glucose, phosphorus, total protein, triglycerides, urea nitrogen, and uric acid.
CODE List #1E65-01 and Lot #54650M100.
MANUFACTURER Medical Analysis Systems, Inc., Camarillo, California.
RECALLED BY Abbott Laboratories, Inc., Irving, Texas
DISTRIBUTION Nationwide, Mexico, Venezuela, Colombia, Dominican Republic, Canada, Germany, Hong Kong, Singapore, Australia, New Zealand, Curaco..
QUANTITY 1,733 kits were distributed.
REASON The stability failure of the multiconstituent calibrator (MCC). Creatinine concentration has decreased from the test June 1, 2000 due to high iron content. The decrease in creatinine concentration in the MCC may result in an upward shift of creatinine results of up to 12%. The expiration date of this lot is November 3, 2000.

WEEK ENDING DECEMBER 29
 

PRODUCT FastTake Compact Blood Glucose Monitoring System, used to quantitatively measure glucose (sugar) levels in whole blood taken during home-care use, under the following trade names:One Touch FastTake Compact Blood Glucose Monitoring System (in the U.S. and Canada); PocketScan Compact Blood Glucose Monitoring System (in the United Kingdom); EuroFlash Compact Blood Glucose Monitoring System (in Europe); SmartScan Compact Blood Glucose Monitoring System (in Asia, Middle East, Africa, Europe). 

CODE All meters with serial numbers starting with K, L, M and N.

MANUFACTURER Inverness Medical, Inc., Waltham, Massachusetts.

RECALLED BY LifeScan, Inc., Milpitas, California

DISTRIBUTION Nationwide.

QUANTITY 846,874 meters were distributed.

REASON The meter may display a "y" character instead of a number in the test result.

 

PRODUCT VITROS Chemistry Slides: (1) Albumin chemistry slides - labeled "ALB Slides", for quantitative measurement of albumin concentrations in serum or plasma (Catalog #819 6057);

(2) BUN/Urea Chemistry Slides, labeled "BUN slides", for quantitative measurement of urea nitrogen concentration in serum, plasma and urine (Catalog #174 3418);

(3) Glucose Chemistry Slides, labeled "GLU Slides", for quantitative measurement of glucose concentrations in serum, plasma, urine and CSF (Catalog #170 7801);

(4) Potassium Chemistry Slides, labeled "K+ Slides", for the quantitative measurement of

potassium concentrations in serum, plasma, and urine (Catalog #161 6200). 

CODE a) 0914-0169-1087, 0914-0169-1089, 0913-0170-1078; b) 0111-0503-1067; c) 0001-0543-1017, xxx1018, xxx1020, xxx1028, xxx1029, and xxx1327; d) 4102-0394-1038, xxx1104, and xxx1106.

MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, New York.

DISTRIBUTION Nationwide.

QUANTITY 3,846 packs were distributed.

REASON The moisture content (humidity) inside the cartridge sleeve might be lower than is typical for these products.   The Slides are conditioned at a defined temperature and relative humidity before packaging to optimize performance and handling.  The effect of this deviation on shelf life and on-board stability are unknown.  Stability claims may not be met and performance may not be effective for intended use.

 

PRODUCT Dall-Miles Cable System, Dall-Miles Beaded Cable Sleeve Set, Wire Surgical, used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Product is gamma sterilized. 

CODE Lot Numbers: IGTW01, IGTX01, IGTZ01.

MANUFACTURER SAVA Industries, Inc., Riverdale, New Jersey.

RECALLED BY Howmedica Osteonics Corp., Rutherford, New Jersey

DISTRIBUTION Alabama, California, Connecticut, Florida, Kentucky, Massachusetts, Minnesota, Montana, New York, Oregon, Tennessee, Texas, Utah, Idaho, Indiana, Maryland, Virginia, Germany, England, Switzerland, Spain, Auckland.

QUANTITY 249 units were distributed.

REASON The packages labeled 2.0 beaded cable actually contained non-beaded cable.

 

PRODUCT Bayer ADVIA 120 Automated Hematology Systems:Advia 120 Automated Hematology System;

a) Technicon H1 Hematology Systems;

b) Technicon H2 Hematology Systems;

c) Technicon H3 Hematology Systems;

d) Technicon H1 Jr Hematology Systems;

e) Technicon H1E Hematology Systems. 

CODE All serial numbers.

MANUFACTURER Bayer Diagnostics Mfg., Swords, Co Dublin, Ireland.

RECALLED BY Bayer Corporation, Elkhart, Indiana (distributor)

DISTRIBUTION Nationwide and international.

QUANTITY 1,800 units were distributed.

REASON A customer was sprayed with the contents of the waste tank, since he did not release the pressure before opening