Product Wiki · Recalls · Health Canada — Medical Devices

Various ID-MTS Gel Cards products (2018-04-25) — recall 60907

Health Canada — Medical Devices · Canada · 2018-05-04 · 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
60907
Date of alert
2018-05-04
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Ortho Clinical Diagnostics (Ortho) has initiated this recall as it may potentially affect the ID-MTS Gel Cards. The gel card trays are stored in paper board trays. The gel card trays may contain an increased amount of white dust/debris from the trays that can adhere to the outer surface of the cards. Ortho has confirmed reports of white dust/debris on the outer surface of various ID-MTS Gel Cards products. While the issue does not affect use of the ID-MTS Gel Cards in manual method, Ortho has identified that the adhering of white dust/debris on the outer surface of the cards may potentially affect the performance of the cards on ORTHO VISION and ORTHO VISION Max Analyzer.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/various-id-mts-gel-cards-produ

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.