Recall Z-1157-2021— BioFire Diagnostics, LLC

Name: FDA recall Z-1157-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-26

Class II · Terminated

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2021-01-26, terminated 2022-05-02. It names one FDA 510(k) clearance: K181493. Product: Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only. Reason: The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-01-26
Terminated: 2022-05-02
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

Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

Reason for recall

The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.

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