Recall Z-1877-2025— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2025-04-30. FDA's recall record names no specific 510(k) clearance for this event. Product: BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems. Reason: Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-30
- Firm location
- Salt Lake City, UT, United States
Product description
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Reason for recall
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.