Biofire Diagnostics, Llc
Salt Lake City, UT
This page shows every FDA and USDA recall linked to Biofire Diagnostics, Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
40
Total Recalls
2018
First Recall
2025
Most Recent
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Nov 26, 2025
· Device
Open, Classified
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
May 29, 2025
· Device
Open, Classified
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Apr 4, 2025
· Device
Open, Classified
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Sep 30, 2024
· Device
Open, Classified
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Sep 11, 2024
· Device
Open, Classified
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
Sep 11, 2024
· Device
Open, Classified
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Aug 16, 2024
· Device
Open, Classified
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Aug 16, 2024
· Device
Open, Classified
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116
(30 test kit)
BIOFIRE FILMARRAY Gastrointesti...
Aug 6, 2024
· Device
Open, Classified
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in...
Jul 31, 2024
· Device
Open, Classified
FilmArray Gastrointestinal (GI) Panel
RFIT-ASY-0116 (30 test kit)
RFIT-ASY-0104 (6 test kit)
Gastrointestinal...
Feb 15, 2024
· Device
Open, Classified
BIOFIRE Blood Culture Identification 2 (BCID2) Panel
when used with:
BD BACTEC Lytic Anaerobic medium
BD BACT...
Feb 15, 2024
· Device
Open, Classified
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Feb 6, 2024
· Device
Open, Classified
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Feb 6, 2024
· Device
Open, Classified
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with t...
Jan 10, 2024
· Device
Open, Classified
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnos...
Jan 10, 2024
· Device
Open, Classified
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Co...
Dec 1, 2023
· Device
Open, Classified
FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, to...
Nov 20, 2023
· Device
Open, Classified
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Aug 21, 2023
· Device
Open, Classified
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Aug 21, 2023
· Device
Open, Classified
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Apr 14, 2023
· Device
Open, Classified
In Vitro Diagnostic (IVD) Panel
BioFire BCID2 Panel - REF RFIT-ASY-0147
Mar 15, 2023
· Device
Open, Classified
In Vitro Diagnostic (IVD) Panel
FilmArray GI Panel - REF RFIT-ASY-0116
Mar 15, 2023
· Device
Open, Classified
In Vitro Diagnostic (IVD) Panel
BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
Mar 15, 2023
· Device
Open, Classified
BioFire Blood Culture Identification 2 (BCID2) Panel
Part No: RFIT-ASY-0147
UDI: 00815381020338
Blood Culture...
Oct 11, 2021
· Device
Terminated
FilmArray Blood Culture Identification (BCID) Panel
Product Pouch Label:
FilmArray BCID Panel
Part No:...
Jul 20, 2021
· Device
Terminated
FilmArray Pneumonia Panel plus (Pneumoplus)
Part Numbers:
Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30...
Jun 7, 2021
· Device
Terminated
FilmArray Pneumonia Panel (Pneumo)
Part Numbers:
Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit...
Jun 7, 2021
· Device
Terminated
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro...
May 10, 2021
· Device
Terminated
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Apr 16, 2021
· Device
Terminated
Gram-Negative Bacteria And Associated Resistance Markers;
Film Array Blood Culture Identification (BCID); Fil...
Jan 26, 2021
· Device
Terminated
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for u...
Jan 26, 2021
· Device
Terminated
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/...
Jan 22, 2020
· Device
Terminated
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/A...
Jan 22, 2020
· Device
Terminated
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Onl...
Aug 8, 2019
· Device
Terminated
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics,
REF: RFIT-ASY-0126, and RFIT-ASY-0127,
when used with...
Mar 7, 2019
· Device
Terminated
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC
REF: RFIT-ASY-0104, and RFIT-AS...
Mar 6, 2019
· Device
Terminated
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/...
Oct 30, 2018
· Device
Terminated
-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For...
Sep 10, 2018
· Device
Terminated
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFI...
Apr 25, 2018
· Device
Terminated