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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Event Detail

Event ID 61526
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 2012-03-16
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide; CANADA, BRAZIL, GERMANY, ALGERIA, ESTONIA, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ISRAEL, ITALY, JAPAN, POLAND, ROMANIA, SAUDI ARABIA, SWEDEN, SINGAPORE, TUNISIA, TAIWAN, URUGUAY, SOUTH AFRICA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Life Technologies": BRAND NAME: ABC SSP UniTray® Kit, A Locus SSP UniTray® Kit, ABDR SSP UniTray® Kit, ABDRDQ SSP UniTray® Kit, AllSet+" Gold SSP HLA-A Locus Low Res Kit, AllSet+" Gold SSP HLA-ABC Low Res Kit, AllSet+" Gold SSP HLA-ABDR Low Res Kit, AllSet+" Gold SSP HLA-ABDRDQ Low Res Kit Invitrogen" , 9099 North Deerbrook Trail, Brown Deer, Wisconsin 53223 USA. AllSetGoldSSPHLA-ALowResKit 54310D 021709367 021791391 021858141 021916872 021944913 0211076053; AllSetGoldSSPHLA ABCLowResKit 54340D 037736548 037791458 037841437 037887231 037912911 037981112 0371011633 0371099919; AllSetGoldSSPHLA ABDRLowResKit 54350D 035735485 035757726 035791451 035832512 035866507 035911311 035951701 0351008471 0351073440 0351103719; AllSetGoldSSPHLA ABDRDQLowResKit 54360D 027736541 027778991 028835924 028861758 028911312 028984379 0281073439 0281103699; ABCSSPUniTrayKit 7800010 037712454 037757729 037796665 037851612 037902242 037920508 037979628 0371092252; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037712454752859 037712454758394 037712454760790 037712454764016 037712454766991 037712454770869 037712454771629 037712454772789 037712454774287 037712454778484 037712454778956 037712454781733 037712454788029 037712454789359 037712454790178 037757729798591 037757729797983 037757729801400 037757729804912 037757729808045 037757729812168 037757729814418 037757729815958 037757729819705 037757729821059 037757729825396 037757729827308 037757729828024 037757729830803 037796665832713 037796665834166 037796665838009 037796665838890 037796665844722 037796665847106; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037796665849099 037796665850875 037796665851181 037796665852860 037796665851949 037796665857262 037796665858683 037796665865627 037796665866156 037796665869762 037796665871196 037796665874253 037796665874943 037851612880429 037851612881201 037851612883129 037851612890428 037851612895476 037851612899445 037851612900035 037851612904079 037851612904692 037851612905849 037851612907021 037851612907856 037851612910035 037851612910577 037851612914817 037851612917475 037851612919222 037851612924833 037902242932770 037902242933984 037902242935517 037902242938190 037902242940463 037902242942846 037902242943935 037902242946600 037902242977061 037920508978727 037920508985066 037920508988899; ABCSSPUniTrayKitwithTaqPolymerase 7800110 037920508991179 037920508998068 0379205081007233 0379205081008777 0379205081009666 0379205081012119 0379205081016105 0379205081017791 0379205081022104 0379205081021177 0379205081022614 0379205081025411 0379205081028018 0379205081028598 0379205081030883 0379796281034872 0379796281039558 0379796281041841 0379796281043290 0379796281044774 0379796281047614 0379796281048266 0379796281070125 0379796281073455 0379796281077182 0379796281083262 0379796281084640 0379796281092860 0379796281093721 0379796281097467 0379796281098059 0379796281099188 0379796281101573 0379796281104591 03710922521111533 03710922521113863 03710922521114554 03710922521116675 03710922521123330 03710922521124844; ABDRSSPUniTrayKit 7810010 035709363 035757737 035841438; ABDRSSPUniTrayKit 7810010 035912902 035999103 0351091909; ABDRSSPUniTrayKitwithTaqPolymerase 7810110 035709363752340 035709363757045 035709363764325 035709363770868 035709363771628 035709363784352 035709363792242 035709363794386 035757737795098 035757737801401 035757737812169 035757737820236 035757737833338 035757737835069 035757737838145 035757737851950 035757737864234 035841438883648 035841438897030 035841438900036 035841438924835 035912902946416 0359129021025412 0359991031079276 0359991031096908; ABDRDQSSPUniTrayKit 7850010 027711596 027749793 027785475 028848815 028912903 0281017323; ABDRDQSSPUniTrayKitwithTaqPolymerase7850110 027711596757044 027711596758147 027711596764014 027711596764678 027749793799826 027749793826676 027785475834613; ABDRDQSSPUniTrayKitwithTaqPolymerase7850110 027785475866155 027785475869047 028848815905848 028848815912398 028848815942043 028848815947403 028848815978967 028848815979292 028848815984697 0289129031022118 0289129031036927 02810173231045578 02810173231076646 02810173231090097; ALocusSSPUniTrayKit7860010 021751563 021825655 021912905 021999106; ALocusSSPUniTrayKitwithTaqPolymerase7860110 021751563824723 021825655924846 021825655926945 021825655928179 021825655932194 021825655935516 021912905948130 021912905951091 0219991061082229 ALocusSSPUniTrayKit7860010021751563 2010-032011-10 0218256552010-082012-04 0219129052011-032012-11 0219991062011-082013-03 ALocusSSPUniTrayKitwithTaq Polymerase 78601100217515638247232010-072011-10 0218256559248462011-022012-04 0218256559269452011-022012-04 0218256559281792011-022012-04 0218256559321942011-032012-04 0218256559355162011-032012-04 0219129059481302011-042012-11 0219129059510912011-042012-11 02199910610822292011-102013-03 Class II HLA typing assay, associated with false negative results, were distributed. 12 units B-1713-12
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