Recall Z-2440-2023— BioFire Diagnostics, LLC

Name: FDA recall Z-2440-2023
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. It names 2 FDA 510(k) clearances: K212727, K180966. Product: FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, 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

510(k) clearances named in this recall

2 on FDA's record

K212727 — FilmArray Pneumonia PanelBiofire Diagnostics, LLC·cleared 2021-09-22
K180966 — FilmArray Pneumonia PanelBiofire Diagnostics, LLC·cleared 2018-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, 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.