Recall Z-1903-2021— BioFire Diagnostics, LLC

Name: FDA recall Z-1903-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-10

Class II · Terminated

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2021-05-10, terminated 2022-12-15. It names one FDA 510(k) clearance: K193519. Product: BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338. Reason: Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-05-10
Terminated: 2022-12-15
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K193519 — BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC·cleared 2020-03-18

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

BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

Reason for recall

Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

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