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LABType HD Class II DRB1 Typing Test
- Starting date:
- March 30, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15886
Recalled Products
A. LABType HD Class II DRB1 Typing Test
Reason
The user documenation for this product is missing DRB1*15:50N Allele for Probe on Bead #525. This may generate a sample typing of DRB1*15:04 instead of DRB1*15:04/15:50N. There is low risk of death or serious harm to the patient or end user as a result of this potential product failure.
Affected products
A. LABType HD Class II DRB1 Typing Test
Lot or serial number
07B
Model or catalog number
- RSSOH2B1
- RSSOH2B1X
Companies
- Manufacturer
- One Lambda Inc.