Biofire® Filmarray® Pneumonia (pnplus) Panel Plus
Recall Summary BioFire® FilmArray® Pneumonia (PNplus) Panel Plus is being recalled across Canada due to performance issues with the test. This is a Class I recall, meaning there is a potential serious adverse health consequence or death. The product is a diagnostic test used to identify respiratory pathogens in pneumonia patients.
- Product
- BioFire® FilmArray® Pneumonia (PNplus) Panel Plus
- Reason
- Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2025-08-15
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8b979575-984c-4ae2-b50f-9264c5d91e19