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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 Invitrogen by Life Technologies: 54350D ALLSET GOLD HLA ABDR LOW RES, 54360D ALLSET GOLD HLA ABDRDQ LOW RES, 54370D ALLSET GOLD HLA DR LOW RES SSP, 54380D ALLSET GOLD HLA DRDQ LOW RES,7810010 AB/DR SSP UNITRAY 10 TESTS, 7810110 AB/DR SSP UNITRAY W/TAQ 10 TS, 7820010 DR 4T SSP UNITRAY 40 TESTS,7840010 DR/DQ 2T SSP UNITRAY 20 TESTS,7840110 DR/DQ 2T SSP UNITRAY W/TAQ 20T. 7850010 AB/DR/DQ SSP UNITRAY 10 TESTS 7850110 AB/DR/DQ SSP UNITRAY W/TAQ 10T
Recall Number B-0283-14
Classification Class II
Code Info 54350D: 0361255129, 0361304515, 0361357615 54360D: 0291247232, 0291293558, 0291306794 54370D: 0201205205, 0201303555 54380D: 0301216651, 0301272183, 0311312025, 0311377599 7810010: 0361316325 7810110: 0361316325, 1409712 7820010: 0201216655 7840010: 0301221267, 0311344994 7840110: 03012212671344796, 03012212671346090, 03012212671346863, 03012212671350644, 03012212671352619, 03012212671375757, 03012212671391605, 03012212671393093, 03012212671396221, 03012212671405133, 03012212671417015, 03012212671420379, 03012212671427118, 03012212671429556, 03012212671438257, 03113449941451386, 03113449941452442, 7850010: 0291255127 7850110: 02912551271345427, 02912551271360761, 02912551271378014, 02912551271393696, 02912551271419162, 02912551271427119, 02912551271439780
Product Distributed Qty 11 units
Reason For Recall HLA typing assay, associated with false negative results, were distributed.

Event Detail

Event Id 67048
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 2013-10-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide; CANADA, NS, COLOMBIA, MUMBAI, SINGAPORE, ARGENTINA, BOLIVIA, ISRAEL, NEW ZEALAND, PAKISTAN, INDONESIA, QATAR, JAPAN, VIETNAM, CHINA, TAIWAN, YEMEN, INDIA, LEBANON, EGYPT.
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