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Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02 (2014-03-25)
- Starting date:
- March 25, 2014
- Posting date:
- August 28, 2014
- 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-41233
Recalled products
- Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02
Reason
Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02, the primer in well 1/7/c is incorrect. As a result, the allele C*02:04 cannot be correctly assigned and may cause an ambiguous misassignment to C*02:27:01 and C*02:65. These alleles are very rare occurring.
Affected products
A. Micro SSP Allele Specific HLA Class I DNA Typing Tray-C*02
Lot or serial number
- 002, Batches 001-006
Model or catalog number
- SSPR1-C02
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES