FDA Medical devices recall ·
BioFire Joint Infection (JI) Panel recall
- Recall number
- Z-2067-2026
- Date
- (initiated April 22, 2026)
- Company / brand
- BioFire Diagnostics, LLC
515 S Colorow Dr, Salt Lake City, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 106 kits (3,180 test)
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Why was it recalled?
Contamination to in-vitro diagnostic test may result in false positives.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #s:0883425,0878825/DI: 00815381020192
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.
States: Maryland North Carolina Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2067-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.