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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product Description B17 SSP UniTray® Kit, REF 472303 and 472313; B Locus High Res SSP UniTray® Kit , REF 4730010 and 4730110; AllSet Gold SSP HLA-B17 High Res Kit, Prod.no. 541120D, AllSet Gold SSP HLA-B Locus High Res Kit , Prod.no. 54020D.
Recall Number B-2385-12
Classification Class II
Code Info . 472303 (B17 SSP UniTray Kit): 004743203, 004825654, 004904114, 004944916, 0041047204 472313 (B17 SSP UniTray Kit with Taq Polymerase) 004743203794936, 004743203824725, 004743203867126, 004825654862612, 004825654902239, 004825654903448, 004825654908705, 004825654933983 004904114936659, 004904114943927, 004904114989957, 004904114991724 0049449161006545, 0049449161029905, 0049449161036926, 00410472041097465 4730010 (B Locus High Res SSP UniTray Kit) 008709385, 008757730, 008800850, 008839301, 008873000, 009910766, 009984375 0101103786 4730110 (B Locus High Res SSP UniTray Kit with Taq Polymerase) 008709385760267, 008709385764018, 008709385764321, 008709385770871, 008839301892884, 008839301895965, 008839301900752, 008839301903610, 008709385786802, 008709385790179, 008709385791195, 008709385791779, 008709385792235, 008709385794392, 008709385799832, 008757730812167, 008757730825400, 008757730826478, 008757730827309, 008757730832868, 008757730835072, 008800850838882, 008800850842278, 008800850845743, 008800850849098, 008800850853960, 008800850857260, 008 800850 859419 008800850864238, 008800850874250, 008839301884136, 008839301891810, 008839301907862, 008839301923305, 008873000925324, 008873000940462, 008873000942042, 009910766979658, 009910766990558, 0099107661007232, 0099107661013361, 0099107661016456, 0099107661029333, 0099107661032390, 0099107661038471, 0099107661046552, 0099107661048423, 0099107661070124, 0099843751071655, 0099843751077181, 0099843751112028, 0099843751112356, 0099843751113862, 01011037861143513, 01011037861148166 541120D (AllSet Gold SSP HLA-B17 High Res Kit - 10 Tests) 004744187, 004841439, 0041030324 54020D (AllSet Gold SSP HLA-B Locus High Res Kit - 10 Tests) 008707067, 008775767, 008796669, 008839303, 009910772, 009979631
Product Distributed Qty 6 Units
Reason For Recall HLA typing assay, associated with false negative results, was distributed.

Event Detail

Event Id 62468
Product Type Biologics
Status Ongoing
Recalling Firm Life Technologies, Inc.
City Brown Deer
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and CANADA
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