Product Wiki · Recalls · Health Canada — Medical Devices

Advia Centaur Folate (FOL) Assay — recall 48465

Health Canada — Medical Devices · Canada · 2012-12-10 · 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
48465
Date of alert
2012-12-10
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: The Advia Centaur Assays listed above, show changes in patient samples and quality control values when the ambient temperature of the room or laboratory shifts between 18° C - 30° C where the Advia Centaur system is installed. These assays are not meeting the specifications within the operating temperature range which is 18° C - 30° C . This effect occurs on either the Advia Centaur, Advia Centaur XP, and/or Advia Centaur CP systems depending on the assay and the system.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-folate-fol-assay

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.