Biofire Diagnostics recalls
Biofire Diagnostics appears in 44 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
FDA Device · Class II · 2026-08-19 · Biofire Diagnostics - BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics - Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics - BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
FDA Device · Class II · 2025-12-03 · Biofire Diagnostics - BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
FDA Device · Class II · 2025-06-04 · Biofire Diagnostics - FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
FDA Device · Class II · 2025-04-16 · Biofire Diagnostics - FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
FDA Device · Class II · 2024-09-18 · Biofire Diagnostics - FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
FDA Device · Class II · 2024-09-18 · Biofire Diagnostics - BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
FDA Device · Class II · 2024-08-28 · Biofire Diagnostics - BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
FDA Device · Class II · 2024-08-28 · Biofire Diagnostics - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-01…
FDA Device · Class II · 2024-08-14 · Biofire Diagnostics - BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Medi…
FDA Device · Class II · 2024-08-07 · Biofire Diagnostics - BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC…
FDA Device · Class II · 2024-02-21 · Biofire Diagnostics - FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucle…
FDA Device · Class II · 2024-02-21 · Biofire Diagnostics - FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
FDA Device · Class II · 2024-02-14 · Biofire Diagnostics - FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
FDA Device · Class II · 2024-02-14 · Biofire Diagnostics - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use wit…
FDA Device · Class II · 2024-01-17 · Biofire Diagnostics - 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 B…
FDA Device · Class II · 2024-01-17 · Biofire Diagnostics - BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray…
FDA Device · Class II · 2023-12-13 · Biofire Diagnostics - FilmArray TORCH REF HTFA-ASY-0104
FDA Device · Class II · 2023-11-29 · Biofire Diagnostics - FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
FDA Device · Class II · 2023-09-20 · Biofire Diagnostics - BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
FDA Device · Class II · 2023-08-30 · Biofire Diagnostics - FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
FDA Device · Class II · 2023-08-30 · Biofire Diagnostics - FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
FDA Device · Class II · 2023-04-26 · Biofire Diagnostics - In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics - In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics - In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics - BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 4420…
FDA Device · Class II · 2021-12-08 · Biofire Diagnostics - FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
FDA Device · Class II · 2021-08-18 · Biofire Diagnostics - FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142…
FDA Device · Class II · 2021-07-14 · Biofire Diagnostics - FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 0…
FDA Device · Class II · 2021-07-14 · Biofire Diagnostics - FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
FDA Device · Class II · 2021-06-30 · Biofire Diagnostics - BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (0…
FDA Device · Class II · 2021-06-30 · Biofire Diagnostics - BioFire BCID2 Panel
FDA Device · Class II · 2021-03-10 · Biofire Diagnostics - Gram-Negative Bacteria And Associated Resistance Markers
FDA Device · Class II · 2021-03-10 · Biofire Diagnostics - FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Cata…
FDA Device · Class II · 2020-06-17 · Biofire Diagnostics - FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catal…
FDA Device · Class II · 2020-06-17 · Biofire Diagnostics - FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
FDA Device · Class II · 2020-03-18 · Biofire Diagnostics - FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The Fi…
FDA Device · Class II · 2019-05-08 · Biofire Diagnostics - FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture…
FDA Device · Class II · 2019-04-24 · Biofire Diagnostics - -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (…
FDA Device · Class II · 2018-11-21 · Biofire Diagnostics - FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test k…
FDA Device · Class II · 2018-11-07 · Biofire Diagnostics - FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when…
FDA Device · Class II · 2018-05-02 · Biofire Diagnostics - FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative mul…
FDA Device · Class II · 2014-07-02 · Biofire Diagnostics