Product Wiki · Recalls · Health Canada — Medical Devices

ZYMUTEST HIA IgGAM MonoStrip (2018-02-06) — recall 60771

Health Canada — Medical Devices · Canada · 2018-03-23 · 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
60771
Date of alert
2018-03-23
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A typographical error was identified in the Information for Use (IFU) for the ZYMUTEST HIA MonoStrip. On the section "test procedure" for the reconstitution volume of the immunoconjugate reagent, 7.5ml is written instead of 2ml of conjugate diluent.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/zymutest-hia-iggam-monostrip-2

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.