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Micro SSP High Resolution HLA Class II DNA Typing Trays (2013-11-04)
- Starting date:
- November 4, 2013
- Posting date:
- February 3, 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-37535
Recalled Products
Micro SSP High Resolution HLA Class II DNA Typing Trays
Reason
The use of this product in combination with optional analysis software, HLA Fusion software, may cause misassignment to DRB1*15:65 when positive reactivity is seen in well 11A. With the presence of DRB4*01:03 and DRB5*01:01, only a DRB1*15:65 without DRB1*15:01 typing result is suggested. This is due to a limitation in the software with cross loci wells. Analysis of this product without HLA fusion software will not generate incorrect suggested typing results.
Affected products
Micro SSP High Resolution HLA Class II DNA Typing Trays
Lot or serial number
Lot 005, batches 003-034
Model or catalog number
SSP2H
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES