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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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 Name
Catalog
Identification
Lot
Number
Expiration
Date Range
Micro SSP Allele Specific HLA
Class I Typing Tray - A*11
 
SSP1-11
 
002
 
3/2013
Micro SSP Allele Specific HLA
Class I Typing Tray - A*11
 
SSPR1-11
 
003
 
4/2014
Micro SSP Allele Specific HLA
Class I Typing Tray - A*26
 
SSP1-26
 
01A
 
5/2013
Micro SSP High Resolution
HLA Class II DNA Typing Tray
 
SSP2H
 
04A
 
3/2013
Micro SSP High Resolution
HLA Class II DNA Typing Tray
 
SSP2H
 
005
 
1/2015
Micro SSP Generic HLA Class
II DNA Typing Tray
 
SSP2L
 
007
 
1/2015
Micro SSP Generic HLA Class
II DNA Typing Tray - DRB Only
 
SSP2LB
 
004
 
7/2014
Micro SSP HLA Class I and II
ABDR DNA Typing Tray
 
SSPABDR
 
008
 
2/2014
Micro SSP HLA Class I and II
ABDR DNA Typing Tray
 
SSPABDR
 
009
 
1/2015
Micro SSP HLA Class I and II
ABDR DNA Typing Tray
 
SSPABDRX
 
008
 
1/2014
Micro SSP HLA Class I and II
ABDR DNA Typing Tray
 
SSPABDRX
 
009
 
1/2015
Micro SSP Generic HLA Class
II DNA Typing Tray - DRB/DQB1/DPB1
 
SSPDRQP1
 
001
 
6/2014
Micro SSP Generic HLA Class I
and II DNA Typing Tray - ABDRDQ
 
SSPML02
 
003
 
1/2014
Micro SSP Generic HLA Class I
and II DNA Typing Tray - ABDRDQ
 
SSPML02
 
004
 
1/2015

 
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.