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BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Recalled May 13, 2026 · FDA recall Z-2067-2026 · BioFire Diagnostics
Hazard
Contamination to in-vitro diagnostic test may result in false positives. · FDA Class II
Units
106 kits (3,180 test)
Sold at
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.
Description
Contamination to in-vitro diagnostic test may result in false positives.
Product
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →