Recall Z-2245-2021— BioFire Diagnostics, LLC

Name: FDA recall Z-2245-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-20

Class II · Terminated

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2021-07-20, terminated 2022-12-16. It names one FDA 510(k) clearance: K181493. Product: FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127. Reason: Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-07-20
Terminated: 2022-12-16
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K181493 — FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC·cleared 2018-07-05

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 Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

Reason for recall

Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

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