BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Recalling company
- BioFire Diagnostics, LLC
- Product
- Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Reason
- Respiratory/sore throat panel test may result in false negative results and control failures.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 1, 2026
- Reported
- May 13, 2026
- Distribution
- US Nationwide distribution in the states of MS, TX MN, VA.
- Status
- Ongoing
- Quantity
- 2400 pouches
- Lot / codes
- Lot Number: 2215125/UDI: 00815381020390
- Company location
- Salt Lake City, UT
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2081-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2081-2026 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.