Product Wiki · Recalls · Health Canada — Medical Devices

Ceruloplasmin for Roche/Hitachi COBAS C Analyzers — recall 56258

Health Canada — Medical Devices · Canada · 2017-01-06 · Type III

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
56258
Date of alert
2017-01-06
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: During an internal investigation the Ceruloplasmin Assay (Cat 20764663322 Lot 19395501/only lot imported in Canada) will need to have the sensitivity limit parameter changed when used on the Cobas C311/C501/C502/C701/C702 until further notice. Higher signals could be generated causing problems with the upper sensitivity limit that could generate error alarms that would prevent performing any measurements.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ceruloplasmin-rochehitachi-cob

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.