Recall Z-0602-2026— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2025-10-22. FDA's recall record names no specific 510(k) clearance for this event. Product: BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit). Reason: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-22
- Firm location
- Salt Lake City, UT, United States
Product description
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Reason for recall
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.