Recall Z-2439-2023— BioFire Diagnostics, LLC

Name: FDA recall Z-2439-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-08

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2023-05-08. FDA's recall record names no specific 510(k) clearance for this event. Product: BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only. Reason: Due to manufacturing issue, panels may result in false negative results..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-05-08
Firm location: Salt Lake City, UT, United States

Product description

BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

Reason for recall

Due to manufacturing issue, panels may result in false negative results.

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