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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2006 Biologics Recalls

Date Notification Brand NameProduct DescriptionReason/ProblemCompany
12/20/2006Notification of BacT/VIEW C.30a Software Update-bioMerieux, Inc.Software Name: BacT/VIEW C.30a Software Update
Affected Instrument Platform: All BacT/ALERT 3D instruments
The supplementary bottle information that will not be sent to the BacT/ALERT instrument when it is entered or changed includes: accession number, bottle type, maximum test time, and bottle status.bioMerieux, Inc.
Durham, North Carolina
12/19/2006Notification of BacT/VIEW Software (all versions)-bioMerieux, Inc.BacT/VIEW Software (all versions)
Product Number:
22105-68 Update Disk
22105-69 Install Disk
Affected Platform: BacT/ALERT Classic Instruments
bioMerieux has recently discovered that the BacT/VIEW will be unable to send new test results to an LIS, perform automatic backups or daily reboots, or run scheduled reports, unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.bioMerieux, Inc.
Durham, North Carolina
12/18/2006Recall of Vironostika HIV-1 Microelisa System-bioMerieux, Inc.Vironostika HIV-1 Microelisa System (Product # 259605, 259717)
Lot Number: 160354
Expiration: April 10, 2007
This recall is being conducted as a result of an internal quality investigation in which bioMerieux was able to confirm one customer complaint of no reactivity on a single coated plate from this lot.bioMerieux, Inc.
Durham, North Carolina
10/20/2006Recovery Notice - Fluvirin (Influenza Virus Vaccine)-Novartis Vaccines and Diagnostics Limited/Cardinal Health CareFluvirin (Influenza Virus Vaccine)
NDC # 66521-109-10 Lot Number/ Expiration Date
71209/ Jun 30 2007
71210/ Jun 30 2007
Novartis recently became aware of some instances where Fluvirin shipped under the CDC contract was received from Cardinal Health Care, in either a frozen state and/or below the required storage temperature.Novartis Vaccines and Diagnostics Limited
Liverpool, United Kingdom
10/2006Recall of Dupaco Blood/Fluid Warming Set-Dupaco, Inc.Product Number: D25480
Lot Numbers: 030603, 030603A, 030145 and 050244
Dupaco has become aware of two leakage failures of the Blood/Fluid Warming Set out of approximately 12,000 distributed.Dupaco, Inc.
Oceanside, California
10/6/2006Recall of Home Access and Home Access Express HIV-1 Test System-Home Access Health CorporationHome Access HIV-1 Test System
Lot Number/ Expiration Date
042108/ May 2007
042109/ May 2007
042110/ June 2007
042111/ August 2007
042113/ August 2007
052101/ November 2007

Home Access Express HIV-1 Test System
Lot Number/ Expiration Date
042010/  February 2007
042011/  February 2007
042012/  May 2007
042013/  May 2007
042014/  May 2007
042015/  August 2007
042016/  August 2007
042017/  August 2007
052001/  August 2007
HAHC has identified that an incorrect "Use By" date was assigned to certain lots of HIV-1 Test Systems manufactured between June 2004 and January 2005.Home Access Health Corporation (HAHC)
Hoffman Estates, Illinois
8/10/2006Field Action Notification - Becton Dickinson (BD) Procount Kit-BD BiosciencesProcount Progenitor Cell Enumeration Kit
Lot Number 45602
Catalog Number 340498
BD Biosciences requests users discontinue further use of Lot 45602 because it has been determined that the expression of CD45PerCP is outside of the specification (low).BD Biosciences
San Jose, California
7/24/2006Important Drug Information - Antihemophilic Factor (Human), Koate DVI-Talecris BiotherapeuticsLot Number: 26N7802
Expiration Date: 2/15/2008
The product carton incorrectly states the amounts for certain product contents. The incorrect information resulted from a typesetting error that omitted the 'µ' symbol.Talecris Biotherapeutics
Clayton, NC
7/24/2006Important Drug Information - Antihemophilic Factor (Human), Koate DVI (3 lots)-Talecris BiotherapeuticsLot Number
  Expiration Date
26N6XW1      11/29/2007
26N6N01       8/30/2007
26N7H01       3/31/2008
The product carton for the referenced lots incorrectly states the amounts for certain product contents. Specifically, the product carton states that the product contains not more than (NMT) 10 µg/mL aluminum.Talecris Biotherapeutics
Clayton, NC
7/21/2006Recall of RAD-SURE Blood Irradiation Indicators-International Specialty Products / Kent Adhesive Products CompanyPRODUCT / LOT NUMBER / EXPIR

RAD-SURE XR Lot Number O15811XR September 2007

RAD-SURE XR Lot Number O15816XR October 2007

International Distribution:
RAD-SURE X-15 Lot Number O15811X15 September 2007

RAD-SURE X-15 Lot Number O15814X15 October 2007

RAD-SURE X-15 Lot Number O15819X15 November 2007

RAD-SURE X-15 Lot Number O15823X15 December 2007
ISP received two complaints from customers in which certain indicators from these lots failed to turn completely black after being irradiated.Kent Adhesive Products Company
Kent, Ohio
7/20/2006Important Customer Notification - Vironostika HIV-1 - bioMerieuxKit Part Number/Kit Lot Number/EnzAbody Lot Number/Kit Expiration Date
259606/121566/1008926/ 1/10/2007
259606/121567/1008926/ 1/10/2007
259606/121568/1008926/ 1/10/2007
259605 & 259717/160342/1011220/ 8/3/2007
259605 & 259717/160339/1011021/ 7/18/2007
bioMerieux, Inc. has become aware of five HIV-1 finished kit lots in the field which have been reported to contain EnzAbody reagent that appears noticeably cloudy and/or flocculent, instead of clear and non-turbid as expected 30 minutes after reconstitution.bioMerieux, Inc.
Durham, NC
6/20/2006Recall of BD CMVScan Card Test Kit-Becton Dickinson DiagnosticsPRODUCT / LOT NUMBER / EXPIRATION DATE:
Catalog No. 255205 (500 tests/kit) / 6095886 / 8/31/2006

Catalog No. 255001 (100 tests/kit) / 6095884 / 8/31/2006

Catalog No. 255126 (30 tests/kit) / 6114596 / 10/31/2006
Becton Dickinson (BD) has determined that these lot numbers of CMVScan test kits may result in false positive results when testing with plasma specimens (EDTA, CPD, CP2D have been reported).Becton Dickinson Diagnostics
Sparks, MD
5/30/2006Recall of Decavac Vaccine-Amerisource Bergen / Sanofi Pasteur, Inc.Decavac Vaccine, 10 x 1, UD Syringe
NDC 49281-291-10
Lot Number - U1703AA
Amerisource Bergen recently discovered that one carton of 300 packages of Decavac Vaccine (each package contains 10 single-dose syringes of the vaccine), from Lot Number U1703AA, exceeded labeled temperature requirements during shipment.Sanofi Pasteur, Inc.
Swiftwater, Pennsylvania
4/26/2006Medical Device Recall - Ranger High Flow Blood / Fluid Warming Disposable Sets-Biotest Laboratories, Inc. / Arizant, Inc.Ranger High Flow Blood / Fluid Warming Disposable Sets
Lots H2057 through H2182
Part Numbers: 24350, 24355, 24365, 24370
High-flow disposable sets for the Ranger blood/fluid warming system may have been assembled with an inverted bubble trap.Biotest Laboratories, Inc.
Minneapolis, Minnesota
3/30/2006Field Correction: Galileo Blood Bank Analyzer-Immucor, IncGalileo Blood Bank Analyzer
Catalog Number 0064997 and 0064999
Immucor has notified their consignees who have Galileo software version 20060220-SP8.1 loaded on their Galileo Blood Bank Analyzers that this version contained a change to the weak D assays (Weak_D and Weak_D_F) in which the pipetting order of the anti-D reagent and Monoclonal Control was reversed.Immucor, Inc.
Norcross, Georgia
3/15/2006Medical Device Notification - Misys Laboratory Blood Bank Module, Version 6.1-Misys Healthcare SystemsMisys Laboratory Blood Bank Module, Version 6.1Blood bank computer software contains a defect that could cause the data being entered to be out of sync with the accession number, patient and/or unit(s) displayed on the screen.Misys Healthcare Systems
Tucson, Arizona
3/9/2006Recall of Allergenic Extracts-Greer LaboratoriesAlternaria alternata Allergenic Extract
Lots: 35818, 37815, 39573, 35919, 36971, 38393, 40452, 34738, 35648, 37027, 37029, 40020, 40293, 36423, 37729, 34951, 36422, 36421

Geotrichum candidum, Allergenic Extract
Lots: 33548 and 36481

AASC Mold-4 Mix, Allergenic Extract
Lot: 34012
Greer Laboratories is recalling the above mentioned lots as they were labeled with incorrect PNU/mL concentrations.Greer Laboratories, Inc.
Lenoir, North Carolina
 
2/14/2006Field Correction - Medi-Temp III, Blood and Fluid Warmer-Gaymar Industries, Inc.Medi-Temp III, Blood and Fluid Warmer, Model Number FW600
A20001, A20002, A20003, A20004, A20005, A20006, A20007, A20008, A20009, A20010, A20011, A20012, A20013, A20014, A30002, A30003, A30004, A30005, A30006, A30007, A30008, A30009, A30010, A30011, A30012, A30013, A30014, A30015, A30016, A30017, A30018, A30019, A30020, A30021, A30022, A30023, A30024, A30025, A30027, A30030, A30031, A40001, A40002, A40003, A40004, A40005, A40006, A40007, A40008, A40009, B20001, B20002, B20003, B20004, B20005, B20006, B20007, B20008, B20009, B20010, B20011, B20012, B20013, B20014, B20015, B20016, B20017, B20018, B20020, B20021, B20022, B20023, B20024, B20025, B20026, B20027, B20028, B20029, B20030, B20031, B20032, B20033, B20034, B20035, B20036, B20037, B20038, B20039, B20040, B20043, B20044, B20045, B20046, B20047, B20048, B20049, B20050, B20051, B20052, B20053, B20054, B20055, B20056, B20057, B20058, B20059, B20060, B20061, B20062, B20063, B20064, B20065, B20066, B30001, B30002, B30003, B30004, B30005, B30006, B30007, B30008, B30009, B30010, B30012, B30013, B30014, B30015, B30016, B30017, B30018, B30019, B30020, B30021, B30022, B30023, B30024, B30025, B30026, B30027, B30028, B30029, B30030, C20002, C20003, C20004, C20005, C20006, C20007, C20008, C20009, C20010, C20011, C20012, C20013, C20014, C20015, C20016, C20017, C20018, C20019, C20020, C20021, C20022, C20023, C20024, C20025, C20026, C20027, C20028, C20029, C20030, C20031, C20032, C20033, C20034, C20036, C20037, C20038, C20039, C20041, C20042, C20043, C20044, C20045, C20046, C20047, C20049, C20050, C20051, C20053, C20054, C20055, C20056, C20057, C20058, C20059, C20060, C30001, C30002, C30003, C30004, C30005, C30006, C30007, C30008, C30009, C30010, C30011, C30012, C30013, C30014, C30015, C30016, C30017, C30018, C30019, C30020, C30021, C30022, C30023, C30024, C30025, C30026, C30027, C30028, C30029, C30030, C30031, C30032, C30033, C30034, C30035, C30036, C30037, C30038, C30039, C30040, C30041, C30042, C30043, C30044, C30045, C30046, C30047, C30048, C30049, C30050, C30051, C30052, C30053, C30054, C30055, C30056, C30057, C30058, C30059, C30060, C40001, C40002, C40003, C40004, C40005, C40006, C40007, C40008, C40009, C40010, C40011, C40012, C40013, C40014, C40015, C40016, C40017, C40018, C40019, C40020, C40021, C40022, C40023, C40024, C40025, C40026, C40027, C40028, C40029, C40030, C40031, C40032, C40033, C40034, C40035, C40036, C40037, C40038, C40039, C40040, C40041, C40042, C40043, C40044, C40045, C40046, C40047, C40048, C40049, C40050, C40051, C40052, C40053, C40054, C40055, C40056, C40057, C40058, C40059, C40061, C40062, C40063, C40064, C40065, C40066, C40067, C40068, C40069, C40070, C40071, C40072, C40073, C40074, C40075, C40076, C40077, C40078, C40079, C40080, C40081, C40082, C40083, C40084, C40085, C40086, C40087, C40088, C40089, C40090, C40091, C40092, C40093, C40094, C40095, C40096, C40097, C40098, C40099, C40100, C40101, C40102, C40103, C40104, C40105, C40106, C40107, C40108, C40109, C40110, C40111, C40112, C40113, C40114, C40115, C40116, C40117, C40118, C40119, C40120, C40121, C40122, C40123, C40124, C40125, C40126, C40127, C40128, C40129, D30001, D30002, D30003, D30004, D30005, D30006, D30007, D30008, D30009, D30010, D30011, D30012, D30013, D30014, D30015, D30016, D30017, D30018, D30019, D30020, D30021, E20001, E20002, E20004, E20005, E20007, E20008, E20009, E20010, E20011, E20012, E20017, E20018, E20019, E20020, E20021, E20022, E20024, E20025, E20027, E20028, E20030, E20031, E20032, E20033, E30002, E30003, E30004, E30005, E30006, E30007, E30009, E30010, E30011, E30012, E30013, E30014, E30015, E30016, E30017, E30018, E30019, E30020, E30021, F20001, F20002, F20003, F20004, F20005, F20006, F20007, F20008, F20009, F20010, F20011, F20012, F20013, F20014, F20015, F20016, F20017, F20018, F20019, F20020, F20021, F20022, F20023, F20024, F20025, F20027, F20028, F20029, F20030, F20031, F20032, F20033, F20034, F20035, F20036, F20037, F20038, F20039, F20040, F20041, F20042, F20043, F20044, F20045, F20046, F20047, F20048, F20049, F20050, F20051, F20052, F20053, F20054, F20055, F20056, F20057, F20058, F20059, F20060, F20061, F20062, F20063, F20064, F20065, F20066, F20067, F20068, F20069, F20070, F20071, F20072, F20073, F20074, F20076, F20077, F20078, F20080, F20081, F20082, F20083, F20084, F20085, F20086, F20087, F20088, F20089, F20090, F20091, F20092, F20093, F20094, F20095, F20096, F20097, F20098, F20099, F20101, F20102, F20103, F30001, F30002, F30003, F30004, F30005, F30006, F30007, F30008, F30009, F30010, F30011, F30012, F30013, F30014, F30015, F30016, F30017, F30018, F30020, F30021, F30022, F30023, F30025, F30026, F30027, F30028, F30029, F30030, F30031, F30032, F30033, F30034, F30035, F30036, F30037, F30038, F30039, F30040, F30041, F30042, F30043, F30044, F30045, F30047, F30048, F30050, F30052, F30053, F30054, F30056, F30057, F30058, F30059, F30060, F30061, F30062, F30063, F30064, F30066, F30067, F30068, F30069, F30070, F30071, F30072, F30073, F30074, F30076, F30077, F30078, F30079, F30081, F30082, F30083, F30084, F30086, F30087, F30088, F30089, F30090, F30091, F30092, F30093, F30094, F30095, F30096, F30097, G20001, G20002, G20003, G20004, G20005, G20006, G20007, G20008, G20009, G20010, G20011, G20012, G20013, G20014, G20015, G20016, G20017, G20018, G20019, G20020, G20021, G20022, G20023, G20024, G20025, G20026, G20027, G20028, G30001, G30002, G30003, G30004, G30005, G30006, G30007, G30008, G30009, G30010, G30011, G30012, G30013, G30014, G30015, G30016, G30017, G30018, G30019, G30020, G30021, G30022, G30023, G30024, G30025, G30026, G30027, G30028, G30029, G30030, G30031, G30032, G30033, G30034, G30035, G30036, G30037, G30038, G30039, G30040, G30041, G30042, H20001, H20002, H20003, H20004, H20005, H20006, H20007, H20008, H20009, H20010, H20011, H20016, H20017, H20018, H20019, H20020, H20021, H20022, H20023, H20024, H30001, H30002, H30003, H30004, H30005, H30006, H30007, H30008, H30010, H30011, H30012, H30013, H30014, H30015, H30016, H30017, H30018, H30019, H30020, H30022, H30023, H30024, H30025, H30026, H30027, H30028, H30029, H30030, H30031, H30032, H30033, H30034, H30035, H30036, H30037, H30038, H30039, H30040, H30041, H30042, H30043, H30044, H30045, H30046, H30047, H30048, H30049, H30050, H30051, H30052, H30053, H30054, H30055, H30056, H30057, H30058, H30059, H30060, H30061, H30062, H30063, H30064, H30065, H30066, H30067, H30068, H30069, H30070, H30071, H30072, H30073, I20001, I20002, I20003, I20005, I20007, I20008, I20009, I20010, I20011, I20012, I20013, I20014, I20016, I20017, I20018, I20019, I20020, I20021, I20022, I20023, I20024, I20025, I20026, I20027, I20028, I20029, I20030, I20031, I20032, I20033, I20035, I20036, I20037, I30001, I30002, I30003, I30004, I30005, I30006, I30007, I30008, I30009, I30010, I30011, I30012, I30013, I30014, I30015, I30016, I30017, I30019, I30020, I30021, I30022, I30023, I30024, I30025, I30026, I30027, J20001, J20002, J20003, J20004, J20005, J20006, J20007, J20008, J20009, J20010, J20011, J20012, J20013, J20014, J20015, J20016, J20017, J20018, J20019, J20020, J20021, J20022, J20023, J20024, J20025, J20026, J20027, J20028, J20029, J20030, J20031, J20032, J20033, J20034, J20035, J20036, J20037, J20038, J20039, J20040, J20042, J20043, J20044, J20045, J20048, J20049, J20050, J20051, J20052, J30001, J30002, J30003, J30004, J30006, J30007, J30008, J30009, J30010, J30011, J30012, J30013, J30014, J30015, J30016, J30017, J30020, J30021, J30022, J30023, J30024, J30025, J30026, J30027, J30028, J30029, J30030, J30031, J30032, J30033, J30034, J30035, J30036, J30037, J30038, J30039, J30040, J30041, J30042, J30043, J30044, J30045, J30046, J30047, J30048, J30049, J30050, J30051, J30052, J30053, J30054, J30055, J30056, J30057, J30058, J30059, J30060, J30061, J30062, J30063, J30064, J30065, J30066, J30067, J30068, J30069, J30070, J30071, J30072, J30073, J30074, J30075, J30076, J30077, J30079, J30080, J30081, J30082, K10003, L10001, L20001, L20002, L20004, L20005, L20006, L20007, L20008, L20009, L20011, L20012, L20013, L20014, L20016, L20017, L20018, L20019, L20020, L20021, L20022, L20023, L20024, L20025, L20026, L20027, L20028, L20029, L20030

Medi-Temp III, Blood and Fluid Warmer, Model Number FW601
C40001, C40002, C40003, C40004, C40005, C40006, D40001, D40002, D40003, D40004, D40005, D40006, D40007, D40008, D40009, D40010, D40011, D40012, D40013, D40014, D40015, D40016, D40017, D40018, D40019, D40020

Medi-Temp III, Blood and Fluid Warmer, Model Number FW603
A20001, A20002, A20003, A20004, A20005, A20006, A20007, A20008, A20009, A20010, A20011, A20012, A20013, A20014, A20015, A20016, A20017, A20018, A20019, A20020, A20021, A20022, A20023, A20024, A20025, A20026, A20027, A20028, A20029, A20030, A20031, A20032, A20033, A20034, A20035, A20036, A20037, A30001, A30002, A30003, A30004, A30005, A30006, A30007, A30008, A30009, A30012, A30013, A30014, A30015, A30016, A30017, A30018, A30019, A30020, A30026, A30027, A30028, A30029, A30030, A30031, A30032, A30033, A30034, A30040, A30041, A30042, A30043, A30044, A30045, A30046, A30047, A30048, A30051, A30052, A30053, A30055, A30056, A30057, A30058, A30059, A30060, A30061, A30062, A30063, A30064, A40001, A40002, A40003, A40004, A40005, A40006, A40007, A40008, A40009, A40010, A40011, A40012, A40013, A40014, A40015, A40016, A40017, A40018, A40019, A40020, A40021, A40022, A40023, A40024, A40025, A40026, A40027, A40028, A40029, A40030, B20001, B20002, B20003, B20004, B20005, B20006, B20007, B20008, B20009, B20010, B20011, B20012, B20013, B20014, B30001, B30002, B30003, B30004, B30005, B30006, B30007, B30008, B30009, B30010, B30011, B30012, B30013, B30014, B30015, B30016, B30017, B30018, B30020, B30021, B30022, C20001, C20002, C20003, C20004, C20005, C20006, C20007, C20008, C20009, C20010, C20011, C20012, C20013, C20014, C20015, C20016, C30001, C30002, C30003, C30004, C30005, C30006, C30007, C30008, C30009, C30010, C30011, C30012, C30013, C30014, C30015, C30016, C30017, C30018, C30019, C30021, D30001, D30002, D30005, D30006, D30007, D30008, D30009, D30010, D30011, D30012, D30013, D30014, D30015, D30016, D30017, D30018, D30019, D30020, D30026, D30027, D40001, D40002, D40003, D40004, D40005, D40006, D40007, D40008, D40009, D40010, D40011, D40012, D40013, D40014, D40015, D40016, D40017, D40018, D40019, D40020, D40021, D40022, D40023, D40024, D40025, D40026, D40027, E20001, E20002, E20003, E20004, E30001, E30002, E30003, E30004, E30005, E30006, E30007, E30008, E30009, E30010, E30011, E30012, E30013, E30014, E30015, E30016, E30017, E30018, E30019, E30020, E30021, F20001, F20002, F20003, F20004, F20005, F20006, F20007, F20008, F20009, F20010, F20011, F20012, F20013, F20014, F30001, F30002, F30003, F30004, F30005, F30006, F30007, F30008, F30009, F30010, F30011, F30012, F30013, F30014, F30015, F30016, F30017, F30018, F30019, F30020, G20001, G20002, G20003, G20004, G20005, G20006, G20007, G20008, G20009, G20010, G20011, G20012, G20013, G20014, G20015, G20016, G20017, G20018, G20019, G20020, G30001, G30002, G30003, G30004, G30005, G30006, G30007, G30008, G30009, G30010, H20001, H20002, H20003, H20004, H20005, H20006, H20007, H20008, H20009, H20010, H20011, H20012, H20013, I20001, I20002, I20003, I20004, I20005, I20006, I20007, I20008, I20009, I20010, I20011, I20012, I20013, I20014, I20015, I20016, I20017, I20018, I20019, I20020, I20021, I20022, I20023, I30001, I30002, I30003, I30004, I30005, I30006, I30007, I30008, I30009, I30010, I30011, I30012, I30013, I30014, I30015, I30016, I30017, I30018, I30019, I30020, I30021, I30022, I30023, I30024, I30025, I30026, I30027, I30027, I30028, I30029, I30030, I30031, I30032, I30033, I30034, I30035, I30036, K10001, K10002, K10003, L20001, L20002, L20003, L20004, L20005, L20006, L20007, L20008, L20009, L20010, L20011, L20012, L20013, L20014, L20015, L20016, L20017, L20018, L20019, L20020, L20021, L20022, L20023, L20024, L20025, L20026, L20027, L20028, L20029, L30001, L30002, L30003, L30004, L30005, L30006, L30007, L30008, L30009, L30010, L30011, L30012
Gaymar Industries has discovered that blood warmers manufactured prior to April 1, 2004, may have a defective label on the front panel of the unit.Gaymar Industries, Inc.
Orchard Park, New York
1/25/2006Device Correction: Operator’s Manual for Baxter Fenwal Amicus Separator-Baxter Healthcare CorpOperator’s Manual for Baxter Fenwal Amicus Separator Apheresis Device
Product Code 4R2332 (All Serial Numbers)

Amicus Separators Apheresis Devices
Product Codes 4R4580 and 4R4580R (All Serial Numbers)
Baxter has become aware of the remote possibility for hemolyzed blood to be returned to the donor after a specific maintenance procedure.Baxter Healthcare Corporation
Largo, Florida