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Olerup SSP - SSP Combi Trays (2014-05-29)
- Starting date:
- May 29, 2014
- Posting date:
- July 15, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40443
Recalled products
- Olerup SSP - SSP Combi Trays
Reason
Complaint received on kit used for evaluation testing in ring trial (testing with known DNA's in France). A*74:07 allele is not amplified by primer mix 19 as stated in product documentation. This has been corrected in the specificity and interpretation tables. The false negative yields a revised reactivity pattern for the A*74:07 allele that is identical to the A*32:01:14, A*32:03 and A*32:38 pattern.
Affected products
A. Olerup SSP - SSP Combi Trays
Lot or serial number
- Lot 64S
Model or catalog number
- 101.702-24U
Companies
- Manufacturer
-
Olerup SSP AB
Franzengatan 5
Stockholm, Sweden, 11251