Product Wiki · Recalls · Health Canada — Medical Devices

Inhibin B Gen II ELISA — recall 77068

Health Canada — Medical Devices · Canada · 2025-03-06 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
77068
Date of alert
2025-03-06
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: Beckman Coulter has determined that the affected Inhibin B Gen II ELISA reagent lots may provide elevated results. This increase is not detectable by kit controls. Their investigational data confirmed an average increase of about 15% with the maximum reported increase of an individual sample of +44%. Recall Start Date: February 17, 2025
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/inhibin-b-gen-ii-elisa

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