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Lifecodes HLA-C eRES SSO Typing Kit (2016-05-02)
- Starting date:
- May 2, 2016
- Posting date:
- May 16, 2016
- 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-58394
Affected products
- Lifecodes HLA-C eRES SSO Typing Kit
Reason
It has been determined that the threshold set for HLA-C eRES probes 380, 382, 384 and 385 are set high and may result in false negative probe results. The probes resolve the following CWD alleles probe 380 resolves c*03:06, probe 382 resolves c*12:13, probe 384 resolves c*01:08 and probe 385 resolves c*08:06.
Affected products
A. Lifecodes HLA-C eRES SSO Typing Kit
Lot or serial number
Lot # 10235B
Model or catalog number
- 628921
Companies
- Manufacturer
-
Immucor Transplant Diagnostics, Inc.
550 West Avenue
Stamford
06902
Connecticut
UNITED STATES