BioFire Joint Infection Panel REF: RFIT-ASY-0138 recalled over fire hazard

Recall date

April 22, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Recall number

Z-2067-2026

FDA classification

Class II

Brand / firm

BioFire Diagnostics, LLC

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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