Inhibin B Gen II ELISA
Brand(s)
Last updated
Summary
Product
Inhibin B Gen II ELISA
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Inhibin B Gen II ELISA | 240918D 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Immunotech S.R.O.
Radiova 1122/1, Praha 10, Czech Republic, 10200
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77068
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