Recall Z-2040-2021— BioFire Diagnostics, LLC

Name: FDA recall Z-2040-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-07

Class II · Terminated

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2021-06-07, terminated 2023-07-31. It names one FDA 510(k) clearance: K181324. Product: FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit). Reason: Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-06-07
Terminated: 2023-07-31
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K181324 — FilmArray Pneumonia Panel plusBiofire Diagnostics, LLC·cleared 2018-11-15

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 plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)

Reason for recall

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

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