Class II

Medical Device Recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

BioFire Diagnostics, LLC · April 22, 2026

Reason for Recall

Contamination to in-vitro diagnostic test may result in false positives.

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 Affected

NATIONWIDE

Quantity Affected

106 kits (3,180 test)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2067-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.