Vaccines, Blood & Biologics

Urgent Medical Device Recall / Field Safety Notice - Micro SSP DNA Typing Trays

DATE RECALL INITIATED: February 21, 2013

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Micro SSP™ DNA Typing Trays
Affected Product Details

Product NameCatalog IdentificationLot NumberExpiration Date Range
Micro SSP Allele Specific HLA
Class I Typing Tray - A*11
SSP1-110023/2013
Micro SSP Allele Specific HLA
Class I Typing Tray - A*11
SSPR1-110034/2014
Micro SSP Allele Specific HLA
Class I Typing Tray - A*26
SSP1-2601A5/2013
Micro SSP High Resolution HLA
Class II DNA Typing Tray
SSP2H04A3/2013
Micro SSP High Resolution HLA
Class II DNA Typing Tray
SSP2H0051/2015
Micro SSP Generic HLA
Class II DNA Typing Tray
SSP2L0071/2015
Micro SSP Generic HLA
Class II DNA Typing Tray - DRB Only
SSP2LB0047/2014
Micro SSP HLA
Class I and II ABDR DNA Typing Tray
SSPABDR0082/2014
Micro SSP HLA
Class I and II ABDR DNA Typing Tray
SSPABDR0091/2015
Micro SSP HLA
Class I and II ABDR DNA Typing Tray
SSPABDRX0081/2014
Micro SSP HLA
Class I and II ABDR DNA Typing Tray
SSPABDRX0091/2015
Micro SSP Generic HLA
Class II DNA Typing Tray - DRB/DQB1/DPB1
SSPDRQP10016/2014
Micro SSP Generic HLA
Class I and II DNA Typing Tray - ABDRDQ
SSPML020031/2014
Micro SSP Generic HLA
Class I and II DNA Typing Tray - ABDRDQ
SSPML020041/2015

MANUFACTURER:

One Lambda, Inc.
Canoga Park, CA

REASON:

One Lambda, Inc. part of ThermoFisher Scientific, is voluntarily recalling Micro SSP DNA Typing Trays. Null allele information on the lot specific documents for these products is incorrect and may cause a mis-assignment. The root cause investigations determined that null allele entries during nomenclature update were not verified per the standard operating procedure. No adverse events or product complaints have been received. Consignees are asked to review test results generated with the above mentioned products, impacted test results may need to be further investigated by HLA Laboratory Director. No action required on product lots, products are acceptable for use with revised lot specific user documents. Consignees who have additional questions or concerns may contact One Lambda’s Customer Support team for assistance.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Page Last Updated: 08/20/2014
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