Biofire® Filmarray® Gastrointestinal (gi) Panel
Recall Summary The BioFire FilmArray Gastrointestinal (GI) Panel, a diagnostic test used to identify gastrointestinal infections, is being recalled in Canada due to performance issues. The test may not accurately detect certain pathogens, which could affect the reliability of results for patients. This recall affects all BioFire FilmArray GI Panel products distributed throughout Canada.
- Product
- Biofire® Filmarray® Gastrointestinal (Gi) Panel
- Reason
- Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2024-02-09
- Status
- Closed
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e809d419-89f5-433b-a42d-849a9022382f