BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1
- Recalling company
- BioFire Diagnostics, LLC
- Product
- BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- Reason
- Due to increase in false negative results
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 24, 2026
- Reported
- Aug 19, 2026
- Distribution
- U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
- Status
- Ongoing
- Quantity
- 2,370 pouches (79 kits)
- Lot / codes
- Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
- Company location
- Salt Lake City, UT
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2936-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2936-2026 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.