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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description 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.
Recall Number B-0282-14
Classification Class II
Code Info 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
Product Distributed Qty 12 units
Reason For Recall HLA typing assay, associated with false negative results, were distributed.

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.
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