Company · US
BioFire Diagnostics, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (2 in 12 months)
47recalls (7 in 12 months)
35recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 19 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 14 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 13 |
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System | 8 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 7 |
| QBH | Lower Respiratory Microbial Nucleic Acid Detection System | 4 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 3 |
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 3 |
| QDP | Respiratory Panel | 3 |
| QSN | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System | 3 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 2 |
| NHT | Assay, Nucleic Acid Amplification, Bacillus Anthracis | 1 |
| OEH | Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit | 1 |
| OIH | Yersinia Spp. Reagents | 1 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 1 |
| PZF | Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2026 | K262136 | BIOFIRE SPOTFIRE Vaginitis (VG) Panel Biofire Diagnostics, LLC | PQA |
| Sep 22, 2026 | K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics | QOF |
| Aug 14, 2025 | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini Biofire Diagnostics, LLC | QOF |
| Jan 16, 2025 | K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid Biofire Diagnostics, LLC | PCH |
| Dec 20, 2024 | K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) Biofire Diagnostics, LLC | PEN |
| Nov 7, 2024 | K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Biofire Diagnostics, LLC | PCH |
| May 30, 2024 | K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini Biofire Diagnostics, LLC | QOF |
| Mar 26, 2024 | K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Biofire Diagnostics, LLC | QOF |
| Apr 13, 2023 | K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini Biofire Diagnostics, LLC | QOF |
| Mar 16, 2023 | K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Biofire Diagnostics, LLC | PCH |
| Feb 3, 2023 | K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel Biofire Diagnostics | QOF |
| Oct 27, 2022 | K222601 | FilmArray Pneumonia Panel plus Biofire Diagnostics, LLC | QDS |
| Apr 29, 2022 | DEN200066 | BioFire Joint Infection (JI) Panel Biofire Diagnostics, LLC | QSN |
| Sep 22, 2021 | K212727 | FilmArray Pneumonia Panel Biofire Diagnostics, LLC | QDP |
| Mar 17, 2021 | DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics, LLC | QOF |
| Mar 18, 2020 | K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel Biofire Diagnostics, LLC | PEN |
| Nov 15, 2018 | K181324 | FilmArray Pneumonia Panel plus Biofire Diagnostics, LLC | QDS |
| Nov 9, 2018 | K180966 | FilmArray Pneumonia Panel Biofire Diagnostics, LLC | QDP |
| Jul 5, 2018 | K181493 | FilmArray Blood Culture Identification (BCID) Panel Biofire Diagnostics, LLC | PEN |
| Nov 24, 2017 | DEN170017 | FilmArray Respiratory Panel 2 plus (RP2plus) Biofire Diagnostics, LLC | PZF |
| May 30, 2017 | K170604 | FilmArray Respiratory Panel 2 (RP2) Biofire Diagnostics, LLC | OCC |
| Oct 3, 2016 | K152579 | FilmArray Respiratory Panel EZ (RP EZ) Biofire Diagnostics, LLC | OCC |
| Apr 1, 2016 | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch Biofire Diagnostics, LLC | PCH |
| Mar 17, 2016 | K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch Biofire Diagnostics, LLC | PLO |
| Mar 15, 2016 | K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch Biofire Diagnostics, LLC | PEN |
| Feb 8, 2016 | K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch Biofire Diagnostics, LLC | OCC |
| Oct 8, 2015 | DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel Biofire Diagnostics, LLC | PLO |
| Feb 19, 2015 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 Biofire Diagnostics, LLC | PCH |
| Feb 17, 2015 | K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System Biofire Diagnostics, LLC | OCC |
| Jan 30, 2015 | K143178 | FilmArray 2.0 System Biofire Diagnostics, LLC | NSU |
| Jan 30, 2015 | K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 Biofire Diagnostics, LLC | PEN |
| May 2, 2014 | K140407 | FILMARRAY GASTROINTESTINAL (GI) PANEL Biofire Diagnostics | PCH |
| Aug 5, 2013 | K131930 | JBAIDS ANTHRAX DETECTION KIT Biofire Diagnostics, Inc. | NHT |
| Jul 31, 2013 | K131936 | JBAIDS TULAREMIA DETECTION KIT Biofire Diagnostics, Inc. | OEH |
| Jul 31, 2013 | K131729 | JBAIDS PLAGUE DETECTION KIT Biofire Diagnostics, Inc. | OIH |
| Jun 21, 2013 | K130914 | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL Biofire Diagnostics, Inc. | PEN |
| Feb 11, 2013 | K123620 | FILMARRAY RESPIRATORY PANEL (RP) Biofire Diagnostics, Inc. | OCC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2026 | BioFire Diagnostics, LLC 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 Desc Open, Classified |
QSN | None listed |
| Oct 13, 2026 | BioFire Diagnostics, LLC 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: Open, Classified |
QDS | K243222 |
| Oct 13, 2026 | BioFire Diagnostics, LLC 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 k Open, Classified |
QDP | K243222 |
| Aug 12, 2026 | BioFire Diagnostics, LLC BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742
UDI code: 00815381020529
PCR-based multiplexed nucleic acid test, in vitro diagnostic Open, Classified |
QOF | None listed |
| May 6, 2026 | BioFire Diagnostics, LLC BioFire Joint Infection (JI) Panel
REF: RFIT-ASY-0138, 30 test Kit. Open, Classified |
QSN | None listed |
| May 6, 2026 | BioFire Diagnostics, LLC Biofire Spotfire Respiratory/Sore Throat Panel
REF: 423485 Open, Classified |
QOF | K232954 |
| Nov 26, 2025 | BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) Open, Classified |
QOF | None listed |
| May 29, 2025 | BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems Open, Classified |
OCC | None listed |
| Apr 4, 2025 | BioFire Diagnostics, LLC FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Open, Classified |
QDS | K181324 K222601 +1 |
| Sep 30, 2024 | BioFire Diagnostics, LLC FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software Open, Classified |
PCH | K140407 K143005 +1 |
| Sep 11, 2024 | BioFire Diagnostics, LLC FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U Open, Classified |
OCC | K160068 |
| Sep 11, 2024 | BioFire Diagnostics, LLC FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W Open, Classified |
NSU | K143178 |
| Aug 16, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 Open, Classified |
QDS | None listed |
| Aug 16, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 Open, Classified |
QDS | None listed |
| Aug 6, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116
(30 test kit)
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104
(6 kit test)
The BIOFIRE FILMARRAY Gastrointestinal (GI Open, Classified |
PCH | K140407 K143005 +2 |
| Jul 31, 2024 | BioFire Diagnostics, LLC 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 Open, Classified |
PEN | K193519 |
| Feb 15, 2024 | BioFire Diagnostics, LLC FilmArray Gastrointestinal (GI) Panel
RFIT-ASY-0116 (30 test kit)
RFIT-ASY-0104 (6 test kit)
Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic. Open, Classified |
PCH | K140407 K143005 +2 |
| Feb 15, 2024 | BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 (BCID2) Panel
when used with:
BD BACTEC Lytic Anaerobic medium
BD BACTEC Peds Plus medium
BD BACTEC Plus Aerobic medium
BD BACTEC Plus Anaerobic medium
BD BACTE Open, Classified |
PEN | K193519 |
| Feb 6, 2024 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) Open, Classified |
QBH | K180966 |
| Feb 6, 2024 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) Open, Classified |
QDS | K181324 |
| Jan 10, 2024 | BioFire Diagnostics, LLC 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 BIOFIRE FILMARRAY Torch Systems. Open, Classified |
QOF | None listed |
| Jan 10, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems. Open, Classified |
PCH | K140407 K143005 +2 |
| Dec 1, 2023 | BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Con Open, Classified |
PEN | K193519 |
| Nov 20, 2023 | BioFire Diagnostics, LLC FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports.
The BioFire FilmArray Torch (BioFire Torch) is an auto Open, Classified |
NSU | None listed |
| Aug 21, 2023 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only Open, Classified |
QBH | K180966 K212727 |
| Aug 21, 2023 | BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only Open, Classified |
QOF | None listed |
| Apr 14, 2023 | BioFire Diagnostics, LLC FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) Open, Classified |
PCH | K140407 K143005 |
| Mar 15, 2023 | BioFire Diagnostics, LLC In Vitro Diagnostic (IVD) Panel
FilmArray GI Panel - REF RFIT-ASY-0116 Open, Classified |
PCH | K140407 K143005 +1 |
| Mar 15, 2023 | BioFire Diagnostics, LLC In Vitro Diagnostic (IVD) Panel
BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742 Open, Classified |
QOF | None listed |
| Mar 15, 2023 | BioFire Diagnostics, LLC In Vitro Diagnostic (IVD) Panel
BioFire BCID2 Panel - REF RFIT-ASY-0147 Open, Classified |
PEN | K193519 |
| Oct 11, 2021 | BioFire Diagnostics, LLC BioFire Blood Culture Identification 2 (BCID2) Panel
Part No: RFIT-ASY-0147
UDI: 00815381020338
Blood Culture Catalog No./Description:
442023/BD BACTEC Plus Aerobic medium in plastic vials
442021/BD Terminated |
PEN | K193519 |
| Jul 20, 2021 | BioFire Diagnostics, LLC FilmArray Blood Culture Identification (BCID) Panel
Product Pouch Label:
FilmArray BCID Panel
Part No: RFIT-ASY-0126
Part No: RFIT-ASY-0127 Terminated |
PEN | K181493 |
| Jun 7, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel plus (Pneumoplus)
Part Numbers:
Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)
Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit) Terminated |
QDS | K181324 |
| Jun 7, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo)
Part Numbers:
Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit)
Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit) Terminated |
QBH | K180966 |
| May 10, 2021 | BioFire Diagnostics, LLC BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338 Terminated |
PEN | K193519 |
| Apr 16, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 Terminated |
QBH | K180966 |
| Jan 26, 2021 | BioFire Diagnostics, LLC BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems. Terminated |
PEN | K193519 |
| Jan 26, 2021 | BioFire Diagnostics, LLC Gram-Negative Bacteria And Associated Resistance Markers;
Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems.
Part No: RFIT- Terminated |
PEN | K181493 |
| Jan 22, 2020 | BioFire Diagnostics, LLC FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description:
410851/BACT/ALERT FA Plus
410852/BAC Terminated |
PEN | K130914 K143171 +2 |
| Jan 22, 2020 | BioFire Diagnostics, LLC FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description:
410851/BACT/ALERT FA Plus
410852/BA Terminated |
PEN | K130914 K143171 +2 |
| Aug 8, 2019 | BioFire Diagnostics, LLC FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only Terminated |
PCH | K140407 K143005 +1 |
| Mar 7, 2019 | BioFire Diagnostics, LLC FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics,
REF: RFIT-ASY-0126, and RFIT-ASY-0127,
when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/4 Terminated |
PEN | K130914 K143171 +2 |
| Mar 6, 2019 | BioFire Diagnostics, LLC FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC
REF: RFIT-ASY-0104, and RFIT-ASY-0116),
Product Usage:
The FilmArray Gastrointestinal (GI) Panel is a qualitative multip Terminated |
PCH | K140407 |
| Oct 30, 2018 | BioFire Diagnostics, LLC FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI:
RFIT-ASY-0126 (30 test kit)/ 00815381020086,
RFIT-ASY-0127 (6 test kit)/ 00815381020 Terminated |
PAM | K130914 K143171 +2 |
| Sep 10, 2018 | BioFire Diagnostics, LLC -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD
-Fitment Label (P/N RF Terminated |
PLO | None listed |
| Apr 25, 2018 | BioFire Diagnostics, LLC FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catal Terminated |
PEN | K130914 K143171 +1 |
| Jun 20, 2014 | BioFire Diagnostics, Inc. FirmArray Blood Culture Identification (BCID) Panel, Model 2.0
The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designe Terminated |
PAM | K130914 |