Product Wiki · Recalls · Health Canada — Medical Devices

OLERUP SSP HLA-A (2016-05-04) — recall 55394

Health Canada — Medical Devices · Canada · 2016-05-24 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
55394
Date of alert
2016-05-24
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/olerup-ssp-hla-2016-05-04

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.