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LIFECODES HLA-DQA1/B1 Typing Kit (2015-12-22)
- Starting date:
- December 22, 2015
- Posting date:
- January 14, 2016
- 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-56644
Affected Products
A. LIFECODES HLA-DQA1/B1 Typing Kit
Reason
Immucor Transplant Diagnostics Inc., is investigating a single instance of false positive reactivity of probe dqb253 associated with an allele pair of DQB1*03:03:02:01, DQB1*03:04:01. A false positive result causes the exclusion of DQB1*03:03:02:01/ 03:04:01 as a possible allele combination. The false positive reactivity is only observed in a DQB1*03:03:02:01, DQB1*03:04:01 heterozygous combination. Other combinations with DQB1*03:03:02:01 or DQB1*03:04:01 are not affected.
Affected products
A. LIFECODES HLA-DQA1/B1 Typing Kit
Lot or serial number
- 07065B
- 11184C
Model or catalog number
628930
Companies
- Manufacturer
-
Immucor Transplant Diagnostics, Inc.
550 West Avenue
Stamford
06902
Connecticut
UNITED STATES