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Health Canada Medical devices

Inhibin B Gen II ELISA

Issued March 6, 2025
Issue
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
Hazard description
Performance
Product
Product name
Inhibin B Gen II ELISA
Reference
ID
RA-77068