BioFire Diagnostics, LLC
25 recalls on record · Latest: Jun 4, 2025
FDA Devices Moderate Jun 4, 2025
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
FDA Devices Moderate Apr 16, 2025
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
FDA Devices Moderate Sep 18, 2024
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
FDA Devices Moderate Aug 28, 2024
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
FDA Devices Moderate Aug 28, 2024
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
FDA Devices Moderate Aug 14, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6…
FDA Devices Moderate Aug 7, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles:…
FDA Devices Moderate Feb 21, 2024
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic ac…
FDA Devices Moderate Feb 14, 2024
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
FDA Devices Moderate Jan 17, 2024
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FIL…
FDA Devices Moderate Dec 13, 2023
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Con…
FDA Devices Moderate Sep 20, 2023
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
FDA Devices Moderate Aug 30, 2023
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
FDA Devices Moderate Aug 30, 2023
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
FDA Devices Moderate Apr 26, 2023
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
FDA Devices Moderate Mar 22, 2023
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
FDA Devices Moderate Dec 8, 2021
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BAC…
FDA Devices Moderate Jun 30, 2021
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
FDA Devices Moderate Mar 10, 2021
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: int…
FDA Devices Moderate Mar 10, 2021
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
FDA Devices Moderate Jun 17, 2020
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./…
FDA Devices Moderate Mar 18, 2020
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
FDA Devices Moderate May 8, 2019
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmA…
FDA Devices Moderate Apr 24, 2019
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles:…
FDA Devices Moderate Nov 7, 2018