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ALLSET Gold DRB Class II High Resolution Kits and SSP Unitray (2015-02-09)
- Starting date:
- February 9, 2015
- Posting date:
- March 5, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52441
Recalled Products
A. ALLSET GOLD DRB1-13 HIGH RES
B. DRB1-13 SSP UNITRAY 12 TESTS
Reason
The Primer mix in Lane 6 (Primer Mix R13-51B) of the affected products may cause a DRB1*13:50 allele to be typed as a DRB1*13:14 allele. These alleles occur very rarely. This issue is due to limited sequence information available for this allele at the time of release. Due to the recent availability of a sample exhibiting the DRB1*13:50 allele, a new lot-specific comment has been added to the quality control comments alerting users to the possibility of a false negative in Lane 6 with the DRB1*13:50 allele.
Affected products
A. ALLSET GOLD DRB1-13 HIGH RES
Lot or serial number
015 1446996
015 1589779
015 1608927
Model or catalog number
54270D
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
Wisconsin
UNITED STATES
B. DRB1-13 SSP UNITRAY 12 TESTS
Lot or serial number
015 1322626
015 1511957
015 1511957 / 1632888
Model or catalog number
45080-4
45081-4
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
Wisconsin
UNITED STATES