This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
OLERUP SSP HLA-A (2016-05-04)
- Starting date:
- May 4, 2016
- Posting date:
- May 24, 2016
- 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-58510
Affected products
- OLERUP SSP HLA-A
Reason
In kits of A*01, lots 41V, 35X and 83Y, the A*01:04N allele is not amplified by primer-mix 5 as stated in product documentation. The false negative amplification for the A*01 kit yields a revised reactivity pattern for the A*01:04n allele that is identical to A*01:01 alleles.
Affected products
A. OLERUP SSP HLA-A
Lot or serial number
35X
41V
83Y
Model or catalog number
101.411-06U
101.411-24
Companies
- Manufacturer
-
Olerup SSP AB
Franzengatan 5
Stockholm, Sweden, 11251