Recall Z-1944-2021— BioFire Diagnostics, LLC

Name: FDA recall Z-1944-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-16

Class II · Terminated

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2021-04-16, terminated 2024-04-02. It names one FDA 510(k) clearance: K180966. Product: FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144. Reason: Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Terminated: 2024-04-02
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 (Penumo) REF RFIT-ASY-0144

Reason for recall

Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

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