Product Wiki · Recalls · Health Canada — Medical Devices

Liquid Assayed Chemistry Control Premium Plus — recall 74126

Health Canada — Medical Devices · Canada · 2023-08-17 · 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
74126
Date of alert
2023-08-17
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: Randox laboratories can confirm that there has been a transcription error in the instructions for use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3, LAE4215, lot 1308UE. For caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect. The target and range values are correct. The IFU has been updated and is available on www.randox.com. Incorrect IFU should be discarded and the updated IFU should be downloaded. Recall Start Date: August 3, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/liquid-assayed-chemistry-contr

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.