Official recall record
Inhibin B Gen II ELISA
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-03-06
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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