Vaccines, Blood & Biologics
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2006 Biologics Recalls
| Date Notification | Brand Name | Product Description | Reason/Problem | Company |
|---|---|---|---|---|
| 12/20/2006 | Notification 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 |
| 12/19/2006 | Notification 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 |
| 12/18/2006 | Recall 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 |
| 10/20/2006 | Recovery Notice - Fluvirin (Influenza Virus Vaccine)-Novartis Vaccines and Diagnostics Limited/Cardinal Health Care | Fluvirin (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 |
| 10/2006 | Recall 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 |
| 10/6/2006 | Recall of Home Access and Home Access Express HIV-1 Test System-Home Access Health Corporation | Home 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 |
| 8/10/2006 | Field Action Notification - Becton Dickinson (BD) Procount Kit-BD Biosciences | Procount 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 |
| 7/24/2006 | Important Drug Information - Antihemophilic Factor (Human), Koate DVI-Talecris Biotherapeutics | Lot 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 |
| 7/24/2006 | Important Drug Information - Antihemophilic Factor (Human), Koate DVI (3 lots)-Talecris Biotherapeutics | Lot 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 |
| 7/21/2006 | Recall of RAD-SURE Blood Irradiation Indicators-International Specialty Products / Kent Adhesive Products Company | PRODUCT / 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 |
| 7/20/2006 | Important Customer Notification - Vironostika HIV-1 - bioMerieux | Kit 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 |
| 6/20/2006 | Recall of BD CMVScan Card Test Kit-Becton Dickinson Diagnostics | PRODUCT / 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 |
| 5/30/2006 | Recall 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 |
| 4/26/2006 | Medical 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 |
| 3/30/2006 | Field Correction: Galileo Blood Bank Analyzer-Immucor, Inc | Galileo 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 |
| 3/15/2006 | Medical Device Notification - Misys Laboratory Blood Bank Module, Version 6.1-Misys Healthcare Systems | Misys Laboratory Blood Bank Module, Version 6.1 | Blood 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 |
| 3/9/2006 | Recall of Allergenic Extracts-Greer Laboratories | Alternaria 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 |
| 2/14/2006 | Field 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 |
| 1/25/2006 | Device Correction: Operator’s Manual for Baxter Fenwal Amicus Separator-Baxter Healthcare Corp | Operator’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 |
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