BioFire Diagnostics, LLC
Medical device manufacturer in Salt Lake City, UT.
31510(k) clearances
0PMA approvals
44recalls
Device types
- PEN Gram-Negative Bacteria And Associated… 6
- PCH Gastrointestinal Pathogen Panel Multiplex… 6
- OCC Respiratory Virus Panel Nucleic Acid Assay… 5
- QOF Multi-Target Respiratory Specimen Nucleic… 5
- QDP Respiratory Panel 2
- QDS Mers-Cov And Common Respiratory Pathogens… 2
- OIH Yersinia Spp. Reagents 1
- OEH Joint Biological Agent Identification And… 1
- NHT Assay, Nucleic Acid Amplification, Bacillus… 1
- NSU Instrumentation For Clinical Multiplex Test… 1
- PLO Meningitis/Encephalitis Pathogen Multiplex… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF · Dual Track | 08/14/2025SE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special | 01/16/2025SE |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)…PEN · Special | 12/20/2024SE |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional | 11/07/2024SE |
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniQOF · Special | 05/30/2024SE |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelQOF · Dual Track | 03/26/2024SE |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniQOF · Special | 04/13/2023SE |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Special | 03/16/2023SE |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) PanelQOF · Dual Track | 02/03/2023SE |
| K222601 | FilmArray Pneumonia Panel plusQDS · Special | 10/27/2022SE |
| K212727 | FilmArray Pneumonia PanelQDP · Special | 09/22/2021SE |
| K193519 | BioFire Blood Culture Identification 2 (BCID2) PanelPEN · Traditional | 03/18/2020SE |
| K181324 | FilmArray Pneumonia Panel plusQDS · Traditional | 11/15/2018SE |
| K180966 | FilmArray Pneumonia PanelQDP · Traditional | 11/09/2018SE |
| K181493 | FilmArray Blood Culture Identification (BCID) PanelPEN · Special | 07/05/2018SE |
| K170604 | FilmArray Respiratory Panel 2 (RP2)OCC · Traditional | 05/30/2017SE |
| K152579 | FilmArray Respiratory Panel EZ (RP EZ)OCC · Dual Track | 10/03/2016SE |
| K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchPCH · Special | 04/01/2016SE |
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchPLO · Special | 03/17/2016SE |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchPEN · Special | 03/15/2016SE |
| K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray TorchOCC · Special | 02/08/2016SE |
| K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0PCH · Traditional | 02/19/2015SE |
| K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray SystemOCC · Traditional | 02/17/2015SE |
| K143178 | FilmArray 2.0 SystemNSU · Traditional | 01/30/2015SE |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0PEN · Traditional | 01/30/2015SE |
| K140407 | Filmarray Gastrointestinal (Gi) PanelPCH · Traditional | 05/02/2014SE |
| K131930 | Jbaids Anthrax Detection KitNHT · Traditional | 08/05/2013SE |
| K131936 | Jbaids Tularemia Detection KitOEH · Traditional | 07/31/2013SE |
| K131729 | Jbaids Plague Detection KitOIH · Traditional | 07/31/2013SE |
| K130914 | Filmarray Blood Culture Identification (Bcid) PanelPEN · Traditional | 06/21/2013SE |
| K123620 | Filmarray Respiratory Panel (RP)OCC · Traditional | 02/11/2013SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2936-2026 Class II | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based…Due to increase in false negative results | 06/24/2026Open, Classified |
| Z-2067-2026 Class II | BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.Contamination to in-vitro diagnostic test may result in false positives. | 04/22/2026Open, Classified |
| Z-2081-2026 Class II | Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485Respiratory/sore throat panel test may result in false negative results and control failures. | 04/01/2026Open, Classified |
| Z-0602-2026 Class II | 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… | 10/22/2025Open, Classified |
| Z-1877-2025 Class II | BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systemsDue to manufacturing error, respiratory panel may result in elevated control failures and/or false negative… | 04/30/2025Open, Classified |
| Z-1518-2025 Class II | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374Increased risk of control failures and false negative test results with multiplexed nucleic acid test. | 02/27/2025Open, Classified |
| Z-3123-2024 Class II | FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003USome automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May… | 08/07/2024Open, Classified |
| Z-3122-2024 Class II | FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-WSome automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May… | 08/07/2024Open, Classified |
| Z-2456-2024 Class II | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY…If blood culture identification panel is used in conjunction with specific lots of culture media bottles… | 06/19/2024Open, Classified |
| Z-2683-2024 Class II | BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process… | 06/10/2024Open, Classified |
| Z-2682-2024 Class II | BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process… | 06/10/2024Open, Classified |
| Z-2514-2024 Class II | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE…Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. | 05/16/2024Open, Classified |
| Z-1140-2024 Class II | FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test…Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI)… | 01/26/2024Open, Classified |
| Z-1139-2024 Class II | BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic…Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD… | 01/26/2024Open, Classified |
| Z-0994-2024 Class II | FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test…Their is a potential for false positive results when using Pneumonia panel. | 12/14/2023Open, Classified |
| Z-0993-2024 Class II | FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only…Their is a potential for false positive results when using Pneumonia panel. | 12/14/2023Open, Classified |
| Z-0704-2024 Class II | The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test…A manufacturing event may contribute to elevated rates of false negative results while using… | 11/27/2023Open, Classified |
| Z-0703-2024 Class II | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic…A manufacturing event may contribute to elevated rates of false negative results while using… | 11/27/2023Open, Classified |
| Z-0451-2024 Class II | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with…Routine quality control testing of affected blood culture identification panel with affected control panel… | 10/17/2023Open, Classified |
| Z-0353-2024 Class II | FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which…Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power… | 10/17/2023Open, Classified |
| Z-2440-2023 Class II | FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797…Due to manufacturing issue, panels may result in false negative results. | 05/08/2023Open, Classified |
| Z-2439-2023 Class II | BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx OnlyDue to manufacturing issue, panels may result in false negative results. | 05/08/2023Open, Classified |
| Z-2588-2023 Class II | FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch…The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers… | 04/25/2023Open, Classified |
| Z-1392-2023 Class II | FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30…Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. | 03/08/2023Open, Classified |
| Z-1253-2023 Class II | In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116Due to temperature excursions with products (products being stored outside of the required temperature… | 02/01/2023Open, Classified |
| Z-1252-2023 Class II | In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742Due to temperature excursions with products (products being stored outside of the required temperature… | 02/01/2023Open, Classified |
| Z-1251-2023 Class II | In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147Due to temperature excursions with products (products being stored outside of the required temperature… | 02/01/2023Open, Classified |
| Z-0312-2022 Class II | BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI:…Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause… | 10/11/2021Terminated |
| Z-2245-2021 Class II | FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID…Due to product complaints received for false negative results (dropouts) with blood culture identification… | 07/20/2021Terminated |
| Z-2040-2021 Class II | FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI:…Due to real-time stability study failures resulting in increase rate of false negative results between the 6… | 06/07/2021Terminated |
| Z-2039-2021 Class II | FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI:…Due to real-time stability study failures resulting in increase rate of false negative results between the 6… | 06/07/2021Terminated |
| Z-1903-2021 Class II | BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture…Elevated rates of false negative results may occur when using blood culture panels due to issues in the… | 05/10/2021Terminated |
| Z-1944-2021 Class II | FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to… | 04/16/2021Terminated |
| Z-1158-2021 Class II | BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product…The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels… | 01/26/2021Terminated |
| Z-1157-2021 Class II | Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture…The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels… | 01/26/2021Terminated |
| Z-2296-2020 Class II | FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with…There is an increased risk of false positive Proteus results when using the Film Array Blood Culture… | 01/22/2020Terminated |
| Z-2295-2020 Class II | FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with…There is an increased risk of false positive Proteus results when using the Film Array Blood Culture… | 01/22/2020Terminated |
| Z-1451-2020 Class II | FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI…Complaints have been received concerning elevated rates of false negative results while using the… | 08/08/2019Terminated |
| Z-1133-2019 Class II | FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and…Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture… | 03/07/2019Terminated |
| Z-1242-2019 Class II | FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF:…Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. | 03/06/2019Terminated |
| Z-0446-2019 Class II | -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF…Firm identified an issue in the manufacturing process which might contribute to elevated rates of false… | 09/10/2018Terminated |
| Z-0296-2019 Class II | FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC…Increased risk of false positive results for Proteus when the product is used with a specific blood culture… | 09/05/2018Terminated |
| Z-1513-2018 Class II | FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126…There is an increased risk of false positive Proteus results when the product is used with specific types of… | 03/14/2018Terminated |
| Z-1843-2014 Class II | FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood…BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture… | 05/27/2014Terminated |