Recall Z-2936-2026— BioFire Diagnostics, LLC

Name: FDA recall Z-2936-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-24

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2026-06-24. FDA's recall record names no specific 510(k) clearance for this event. Product: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic. Reason: Due to increase in false negative results.

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-06-24
Firm location: Salt Lake City, UT, United States

Product description

BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Reason for recall

Due to increase in false negative results

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