Recall Monitor
Health Products

Inhibin B Gen II ELISA

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Inhibin B Gen II ELISA
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Inhibin B Gen II ELISA240918D
241022D
241205C
241108C
241022C
241212C		A81303

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

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