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BioFire Diagnostics, LLC

FDA Regulatory Profile

Summary

Total Recalls
41
510(k) Clearances
35
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0602-2026Class IIBioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)October 22, 2025
Z-1877-2025Class IIBioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systemsApril 30, 2025
Z-1518-2025Class IIFilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374February 27, 2025
Z-3123-2024Class IIFILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003UAugust 7, 2024
Z-3122-2024Class IIFILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-WAugust 7, 2024
Z-2456-2024Class IIBIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, wheJune 19, 2024
Z-2682-2024Class IIBIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144June 10, 2024
Z-2683-2024Class IIBIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143June 10, 2024
Z-2514-2024Class IIBIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY May 16, 2024
Z-1139-2024Class IIBIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic mJanuary 26, 2024
Z-1140-2024Class IIFilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) GaJanuary 26, 2024
Z-0993-2024Class IIFilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kitDecember 14, 2023
Z-0994-2024Class IIFilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)December 14, 2023
Z-0704-2024Class IIThe BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for November 27, 2023
Z-0703-2024Class IIBIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitNovember 27, 2023
Z-0353-2024Class IIFilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode sOctober 17, 2023
Z-0451-2024Class IIBIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular October 17, 2023
Z-2439-2023Class IIBioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx OnlyMay 8, 2023
Z-2440-2023Class IIFilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx OnlyMay 8, 2023
Z-2588-2023Class IIFILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module SoftwarApril 25, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K243544BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniAugust 14, 2025
K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidJanuary 16, 2025
K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)December 20, 2024
K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelNovember 7, 2024
K241194BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniMay 30, 2024
K232954BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelMarch 26, 2024
K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniApril 13, 2023
K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelMarch 16, 2023
K213954BIOFIRE SPOTFIRE Respiratory (R) PanelFebruary 3, 2023
K222601FilmArray Pneumonia Panel plusOctober 27, 2022
DEN200066BioFire Joint Infection (JI) PanelApril 29, 2022
K212727FilmArray Pneumonia PanelSeptember 22, 2021
DEN200031BioFire Respiratory Panel 2.1 (RP2.1)March 17, 2021
K193519BioFire Blood Culture Identification 2 (BCID2) PanelMarch 18, 2020
K181324FilmArray Pneumonia Panel plusNovember 15, 2018
K180966FilmArray Pneumonia PanelNovember 9, 2018
K181493FilmArray Blood Culture Identification (BCID) PanelJuly 5, 2018
DEN170017FilmArray Respiratory Panel 2 plus (RP2plus)November 24, 2017
K170604FilmArray Respiratory Panel 2 (RP2)May 30, 2017
K152579FilmArray Respiratory Panel EZ (RP EZ)October 3, 2016