BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1
- Recalling company
- BioFire Diagnostics, LLC
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 22, 2025
- Reported
- Dec 3, 2025
- Distribution
- US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
- Status
- Ongoing
- Quantity
- 97 Kits (2,910 pouches)
- Lot / codes
- UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
- Company location
- Salt Lake City, UT
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0602-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0602-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.