Product Wiki · Recalls · Health Canada — Medical Devices

eSwab — recall 63686

Health Canada — Medical Devices · Canada · 2021-12-07 · 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: 63686
Date of alert: 2021-12-07
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: Copan has received some reports of Bordetella parapertussis false positives observed at high cycle threshold values (Ct, Cycle threshold) when combining eSwab with some in-house PCR protocols and the Pathofinder BV-RealAccurate Quadruplex Bordetella PCR kit due to non-viable B. parapertussis nucleic-acids traces. Recall start date: Nov 5, 2021

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/eswab

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.

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.

eSwab — recall 63686

Related