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SSP Unitray - High Resolution (2013-11-22)
- Starting date:
- November 22, 2013
- Posting date:
- March 25, 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-38619
Recalled Products
SSP Unitray - High Resolution
Reason
A labeling error was identified where a false negative lead to a mistype. Specifically, a primer mix (R15-05C) indicated a false negative for DRB1*15:34/54/66 alleles. This results in a mistype of DRB1*15:34 as DRB1*16:01:02 and DRB1*15:54/66 as DRB1*15:25.
Affected products
SSP Unitray - High Resolution
Lot or serial number
450102D
450112D
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES