Recall Z-0994-2024— BioFire Diagnostics, LLC

Name: FDA recall Z-0994-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-14

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2023-12-14. It names one FDA 510(k) clearance: K180966. Product: FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit). Reason: Their is a potential for false positive results when using Pneumonia panel..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-12-14
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

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: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

Reason for recall

Their is a potential for false positive results when using Pneumonia panel.

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