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Lifecodes HLA-DRB1 Typing Kit (2014-01-29)
- Starting date:
- January 29, 2014
- Posting date:
- March 18, 2014
- 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-38317
Recalled Products
Lifecodes HLA-DRB1 Typing Kit
Reason
Immucor Transplant Diagnostics, Inc. has confirmed HLA-DRB1 Probe 091 has been designed with the incorrect sequence. As a result, the Probe is not expected to react with any alleles, including the three rare alleles for which it was designed to detect: DRB107:20 and 11:86 and 13:16. Analysis with Probe 091 as a false negative does not cause a change in serological typing or level of resolution.
Affected products
Lifecodes HLA-DRB1 Typing Kit
Lot or serial number
05073D
08021A
08021AIVD
10102X
Model or catalog number
628751-50
Companies
- Manufacturer
-
Immucor Transplant Diagnostics, Inc.
550 West Avenue
Stamford
06902
Connecticut
UNITED STATES