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Health product recall

MICRO SSP ALLELE SPECIFIC HLA CLASS I DNA TYPING TRAY-A*02 (2015-02-23)

Starting date:
February 23, 2015
Posting date:
April 2, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-52763

Recalled Products   

MICRO SSP ALLELE SPECIFIC HLA CLASS I DNA TYPING TRAY-A*02

Reason

One Lambda, Inc., part of Thermofisher Scientific, is conducting a correction of the micro SSP allele specific HLA Class I DNA typing TRAY-A*02.  The primer sets in well 3B and 5C are incorrect which may cause a mistype.  Any A*02:01, A*68:02 sample will generate a positive band in well 3B and a negative band in well 5C.  As a result, the HLA fusion software will display an A*02:75, A*68:01/23/59n  typing.

Affected products

MICRO SSP ALLELE SPECIFIC HLA CLASS I DNA TYPING TRAY-A*02

Lot or serial number

006, BATCH 24-25

 

Model or catalog number

SSPR1-A2

 

Companies
Manufacturer

One Lambda Inc

21001 Kittridge Street

Canoga Park

California

UNITED STATES