BioFire Diagnostics, LLC
Salt Lake City, UT, US
BioFire Diagnostics, LLC appears in FDA device records in Salt Lake City, UT. FDA records list 35 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 44 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 35 510(k) clearances for BioFire Diagnostics, LLC between 2013 and 2025. The busiest year on record is 2013, with 5. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 5 |
| 2014 | 1 |
| 2015 | 5 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 3 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | QOF | Substantially Equivalent | |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | PCH | Substantially Equivalent | |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | PEN | Substantially Equivalent | |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | PCH | Substantially Equivalent | |
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | QOF | Substantially Equivalent | |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | QOF | Substantially Equivalent | |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | QOF | Substantially Equivalent | |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | PCH | Substantially Equivalent | |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) Panel | QOF | Substantially Equivalent | |
| K222601 | FilmArray Pneumonia Panel plus | QDS | Substantially Equivalent | |
| DEN200066 | BioFire Joint Infection (JI) Panel | QSN | Unknown | |
| K212727 | FilmArray Pneumonia Panel | QDP | Substantially Equivalent | |
| DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | QOF | Unknown | |
| K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | PEN | Substantially Equivalent | |
| K181324 | FilmArray Pneumonia Panel plus | QDS | Substantially Equivalent | |
| K180966 | FilmArray Pneumonia Panel | QDP | Substantially Equivalent | |
| K181493 | FilmArray Blood Culture Identification (BCID) Panel | PEN | Substantially Equivalent | |
| DEN170017 | FilmArray Respiratory Panel 2 plus (RP2plus) | PZF | Unknown | |
| K170604 | FilmArray Respiratory Panel 2 (RP2) | OCC | Substantially Equivalent | |
| K152579 | FilmArray Respiratory Panel EZ (RP EZ) | OCC | Substantially Equivalent | |
| K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | PCH | Substantially Equivalent | |
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch | PLO | Substantially Equivalent | |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch | PEN | Substantially Equivalent | |
| K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | OCC | Substantially Equivalent | |
| DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel | PLO | Unknown | |
| K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | PCH | Substantially Equivalent | |
| K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | OCC | Substantially Equivalent | |
| K143178 | FilmArray 2.0 System | NSU | Substantially Equivalent | |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 | PEN | Substantially Equivalent | |
| K140407 | FILMARRAY GASTROINTESTINAL (GI) PANEL | PCH | Substantially Equivalent | |
| K131930 | JBAIDS ANTHRAX DETECTION KIT | NHT | Substantially Equivalent | |
| K131936 | JBAIDS TULAREMIA DETECTION KIT | OEH | Substantially Equivalent | |
| K131729 | JBAIDS PLAGUE DETECTION KIT | OIH | Substantially Equivalent | |
| K130914 | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL | PEN | Substantially Equivalent | |
| K123620 | FILMARRAY RESPIRATORY PANEL (RP) | OCC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002773840 | 3002773840 | BioFire Diagnostics, LLC | 515 Colorow Drive, Salt Lake City, UT 84108 US | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHTAssay, Nucleic Acid Amplification, Bacillus Anthracis
- OZZBordetella Pertussis Dna Assay System
- OZYChlamydophila Pneumoniae Dna Assay System
- QMVDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
- PEOFungal Organisms, Nucleic Acid-Based Assay
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- PENGram-Negative Bacteria And Associated Resistance Markers
- PAMGram-Positive Bacteria And Their Resistance Markers
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- OEMHuman Metapneumovirus (Hmpv) Rna Assay System
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
- OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
- NSUInstrumentation For Clinical Multiplex Test Systems
- OEHJoint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
- PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- PZFMers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
- QDSMers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- OZXMycoplasma Pneumoniae Dna Assay System
- OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay
- QSNOrthopedic Infection Microbial Multiplex Nucleic Acid Detection System
- OOUParainfluenza Multiplex Nucleic Acid Assay
- OOIReal Time Nucleic Acid Amplification System
- QDPRespiratory Panel
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- OIHYersinia Spp. Reagents
Recall records
Showing 25 of 44| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2936-2026 | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic | Due to increase in false negative results | Class II | Open, Classified | |
| Z-2067-2026 | BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | Contamination to in-vitro diagnostic test may result in false positives. | Class II | Open, Classified | |
| Z-2081-2026 | Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 | Respiratory/sore throat panel test may result in false negative results and control failures. | Class II | Open, Classified | |
| Z-0602-2026 | BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) | Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. | Class II | Open, Classified | |
| Z-1877-2025 | BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems | Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. | Class II | Open, Classified | |
| Z-1518-2025 | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 | Increased risk of control failures and false negative test results with multiplexed nucleic acid test. | Class II | Open, Classified | |
| Z-3123-2024 | FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA. | Class II | Open, Classified | |
| Z-3122-2024 | FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA. | Class II | Open, Classified | |
| 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 | If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy. | Class II | Open, Classified | |
| Z-2683-2024 | BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 | Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer. | Class II | Open, Classified | |
| Z-2682-2024 | BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 | Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer. | Class II | Open, Classified | |
| Z-2514-2024 | 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) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection. | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. | Class II | Open, Classified | |
| Z-1140-2024 | 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. | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. | Class II | Open, Classified | |
| Z-1139-2024 | 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 BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. | Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums | Class II | Open, Classified | |
| Z-0994-2024 | FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) | Their is a potential for false positive results when using Pneumonia panel. | Class II | Open, Classified | |
| Z-0993-2024 | FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) | Their is a potential for false positive results when using Pneumonia panel. | Class II | Open, Classified | |
| Z-0704-2024 | 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. | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission. | Class II | Open, Classified | |
| Z-0703-2024 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems. | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission. | Class II | Open, Classified | |
| Z-0451-2024 | 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 Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251 | Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results. | Class II | Open, Classified | |
| Z-0353-2024 | 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 automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules. | Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use. | Class II | Open, Classified | |
| Z-2440-2023 | FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only | Due to manufacturing issue, panels may result in false negative results. | Class II | Open, Classified | |
| Z-2439-2023 | BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only | Due to manufacturing issue, panels may result in false negative results. | Class II | Open, Classified | |
| Z-2588-2023 | FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software | The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Class II | Open, Classified | |
| Z-1392-2023 | FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) | Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. | Class II | Open, Classified | |
| Z-1253-2023 | In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 | Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain