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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Event Detail

Event ID 67028
Product Type Biologics
Status Ongoing
Recalling Firm Life Technologies Corporation
City Brown Deer
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-19
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide; GERMANY, AUSTRIA, CANADA, NOVIA SCOTAIA, COLOMBIA, LEBANON, GREECE, PERU, RUSSIA, INDIA, MEXICO, JAPAN, ARGENTIAN, IRELAND, ICE.A D ITALY, NUMBAI, TURKEY, THAILAND, UNITEDKINGDOM, SINGAPORE, FRANCE, BOLIVIA, ESTONIA, ISRAEL, NEW ZEALND, SPAIN, PAKISTAN, INDONESIA, ROMANIA, CHINA, TAIWAN, VIETNAM.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
AllSet+" Gold HLA-A Low Res SSP, 54310D; UniTray® A Locus SSP, 7860010; UniTray® A Locus SSP w/ Taq, 7860110; AllSet+" Gold HLA-ABC Low Res SSP, 54340D; UniTray® ABC SSP, 7800010; UniTray® ABC SSP w/ Taq, 7800110; AllSet+" Gold HLA-AB/DR Low Res SSP, 54350D; UniTray® AB/DR SSP, 810010; UniTray® AB/DR SSP w/ Taq, 7810110; AllSet+" Gold HLA-AB/DR/DQ Low Res SSP, 54360D; UniTray® AB/DR/DQ SSP, 7850010; UniTray® AB/DR/DQ SSP w/ Taq 7850110. 54310D - 0221256853, 0221385981; 860010 - 0221221256, 0221256848; 7860110 - 02212568481376350, 02212568481433358, 02212568481445455; 54340D - 0381249868, 0381306788, 038 360419, 0381391657; 7800010 - 0381221266, 0381322136; 7800110  03812212661319090, 13447951346089, 03812212661353301, 135727113598341369064, 03812212661375756, 03812212661389660, 03812212661393695, 1396220, 03813221361401001, 03813221361405131, 141701414191601420378, 03813221361427117, 142788914367521438256, 03813221361452441; 54350D - 0361255129, 0361304515, 0361357615; 7810010 - 0361316325; 7810110 -03613163251409712; 54360D - 0291247232, 0291293558, 0291306794, 0291362561, 0291395129; 7850010 - 0291255127, 0291414737; 7850110 - 02912551271345427, 02912551271360761, 02912551271378014, 02912551271393696, 02912551271419162, 02912551271427119, 1439780 Class II HLA typing assay, associated with false negative results, were distributed. 12 units B-0282-14
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