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DRB1*04 SSP UniTray Kit
- Starting date:
- September 6, 2012
- Posting date:
- December 10, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16273
Recalled Products
A. DRB1*04 SSP UniTray Kit
Reason
One complaint regarding this issue has been received. Complaint states the DRB1*04 SSP Unitray Kit has a false negative in lane 9 which gives no perfect match typing result for the DRB1*04:32 allele.
Internal investigation has confirmed, with the now available rare sample type, that lane 9 is false negative for the DRB1 *04:32 allele in the listed affected kit according to the labeling provided with the kit. Product does not meet specification. However, the primer mix in lane 9 is functioning as originally intended. The DRB1*04:32 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing.
Affected products
A. DRB1*04 SSP UniTray Kit
Lot or serial number
010 666807
010 727196
011 989163
Model or catalog number
45040-4
Companies
- Manufacturer
- Life Technologies Corp. (Invitrogen)