Biofire Diagnostics, LLC
Biofire Diagnostics, LLC holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2026, with 46 FDA device recalls on record.
Top product codes for Biofire Diagnostics, LLC
FDA recalls by Biofire Diagnostics, LLC
10 most recent of 46- Z-0150-2027 — Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
- Z-0149-2027 — Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
- Z-0148-2027 — Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
- 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
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
- K262136 — BIOFIRE SPOTFIRE Vaginitis (VG) Panel
- 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.