BioFire Diagnostics, LLC recalls BioFire Joint Infection
- Recalling company
- BioFire Diagnostics, LLC
- Product
- BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
- Reason
- Contamination to in-vitro diagnostic test may result in false positives.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 22, 2026
- Reported
- May 13, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.
- Status
- Ongoing
- Quantity
- 106 kits (3,180 test)
- Lot / codes
- Lot #s:0883425,0878825/DI: 00815381020192
- Company location
- Salt Lake City, UT
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2067-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2067-2026 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.