Recall Z-2067-2026— BioFire Diagnostics, LLC

Name: FDA recall Z-2067-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-22

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2026-04-22. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-04-22
Firm location: Salt Lake City, UT, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.