Biofire Diagnostics, LLC
Biofire Diagnostics, LLC holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2025, with 43 FDA device recalls on record.
Top product codes for Biofire Diagnostics, LLC
FDA recalls by Biofire Diagnostics, LLC
10 most recent of 43- Z-2936-2026 — BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
- Z-2067-2026 — BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
- Z-2081-2026 — Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Z-0602-2026 — BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Z-1877-2025 — BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Z-1518-2025 — FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
- Z-3122-2024 — FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
- Z-3123-2024 — FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
- Z-2456-2024 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
- Z-2683-2024 — BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Biofire Diagnostics, LLC
- K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
- K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
- K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
- K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K241194 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
- K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
- K230719 — BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
- K230404 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K222601 — FilmArray Pneumonia Panel plus
- DEN200066 — BioFire Joint Infection (JI) Panel
- K212727 — FilmArray Pneumonia Panel
- DEN200031 — BioFire Respiratory Panel 2.1 (RP2.1)
- K193519 — BioFire Blood Culture Identification 2 (BCID2) Panel
- K181324 — FilmArray Pneumonia Panel plus
- K180966 — FilmArray Pneumonia Panel
- K181493 — FilmArray Blood Culture Identification (BCID) Panel
- DEN170017 — FilmArray Respiratory Panel 2 plus (RP2plus)
- K170604 — FilmArray Respiratory Panel 2 (RP2)
- K152579 — FilmArray Respiratory Panel EZ (RP EZ)
- K160459 — FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
- K160462 — FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
- K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
- K160068 — FilmArray Respiratory Panel (RP) for use with FilmArray Torch
- DEN150013 — FilmArray Meningitis/Encephalitis(ME) Panel
- K143005 — FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
- K143080 — FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
- K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
- K143178 — FilmArray 2.0 System
Data sourced from openFDA. This site is unofficial and independent of the FDA.