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BioFire Diagnostics, LLC: FDA-registered device maker in Salt Lake City, UT, United States, 26 510(k) clearances

Name: BioFire Diagnostics, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

BioFire Diagnostics, LLC is registered with the FDA (registration 3002773840) in Salt Lake City, UT, United States. It lists 22 device types. The FDA files 26 510(k) clearances under its listings, the newest dated September 22, 2026. 35 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002773840
Address: 515 Colorow Drive, Salt Lake City, UT, United States, 84108
Owner or operator: BIOMERIEUX SA (8020790)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
First device listed: October 24, 2014
Registered through: 2026
Brand names listed: BIOFIRE BCID2 Panel, BIOFIRE Blood Culture Identification 2 Panel, BIOFIRE FILMARRAY BCID2 Panel, BIOFIRE FILMARRAY GI Panel, BIOFIRE FILMARRAY GI Panel Mid, BIOFIRE FILMARRAY Gastroinestinal (GI) Panel, BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid and more

Devices it lists

Device	Product code	Class	Role	Source
Bordetella Pertussis Dna Assay System	OZZ	2	Manufacturer	accessdata.fda.gov
Chlamydophila Pneumoniae Dna Assay System	OZY	2	Manufacturer	accessdata.fda.gov
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness	QMV	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Fungal Organisms, Nucleic Acid-Based Assay	PEO	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	PCH	2	Manufacturer	accessdata.fda.gov
Gram-Negative Bacteria And Associated Resistance Markers	PEN	2	Manufacturer	accessdata.fda.gov
Gram-Positive Bacteria And Their Resistance Markers	PAM	2	Manufacturer	accessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	PGX	2	Manufacturer	accessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	2	Manufacturer	accessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	2	Manufacturer	accessdata.fda.gov
Influenza A Virus Subtype Differentiation Nucleic Acid Assay	OEP	2	Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer	accessdata.fda.gov
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System	PLO	2	Manufacturer	accessdata.fda.gov
Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System	QDS	2	Manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Mycoplasma Pneumoniae Dna Assay System	OZX	2	Manufacturer	accessdata.fda.gov
Non-Sars Coronavirus Multiplex Nucleic Acid Assay	OTG	2	Manufacturer	accessdata.fda.gov
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System	QSN	2	Manufacturer	accessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid Assay	OOU	2	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer	accessdata.fda.gov
Respiratory Panel	QDP	2	Manufacturer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 22, 2026	K263054	BIOFIRE Respiratory Panel 2.1 (RP2.1)	QOF	Substantially Equivalent	Biofire Diagnostics	accessdata.fda.gov
August 14, 2025	K243544	BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini	QOF	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
January 16, 2025	K243885	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid	PCH	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
December 20, 2024	K243759	BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))	PEN	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
December 5, 2024	K243463	BIOFIRE FILMARRAY Tropical Fever Panel	QMV	Substantially Equivalent	Biofire Diagnostics, LLC (Biomerieux)	accessdata.fda.gov
November 7, 2024	K242367	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel	PCH	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
November 6, 2024	K243222	BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)	QDS	Substantially Equivalent	Biofire Diagnostics, LLC (Biomerieux)	accessdata.fda.gov
May 30, 2024	K241194	BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini	QOF	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
March 26, 2024	K232954	BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel	QOF	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
April 13, 2023	K230719	BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini	QOF	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
March 16, 2023	K230404	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel	PCH	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
February 3, 2023	K213954	BIOFIRE SPOTFIRE Respiratory (R) Panel	QOF	Substantially Equivalent	Biofire Diagnostics	accessdata.fda.gov
October 27, 2022	K222601	FilmArray Pneumonia Panel plus	QDS	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
April 29, 2022	DEN200066	BioFire Joint Infection (JI) Panel	QSN	Unknown	Biofire Diagnostics, LLC	accessdata.fda.gov
September 22, 2021	K212727	FilmArray Pneumonia Panel	QDP	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
March 17, 2021	DEN200031	BioFire Respiratory Panel 2.1 (RP2.1)	QOF	Unknown	Biofire Diagnostics, LLC	accessdata.fda.gov
March 18, 2020	K193519	BioFire Blood Culture Identification 2 (BCID2) Panel	PEN	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
November 15, 2018	K181324	FilmArray Pneumonia Panel plus	QDS	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
November 9, 2018	K180966	FilmArray Pneumonia Panel	QDP	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
April 1, 2016	K160459	FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch	PCH	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
March 17, 2016	K160462	FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch	PLO	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
February 8, 2016	K160068	FilmArray Respiratory Panel (RP) for use with FilmArray Torch	OCC	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
October 8, 2015	DEN150013	FilmArray Meningitis/Encephalitis(ME) Panel	PLO	Unknown	Biofire Diagnostics, LLC	accessdata.fda.gov
February 19, 2015	K143005	FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0	PCH	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
January 30, 2015	K143178	FilmArray 2.0 System	NSU	Substantially Equivalent	Biofire Diagnostics, LLC	accessdata.fda.gov
May 2, 2014	K140407	FILMARRAY GASTROINTESTINAL (GI) PANEL	PCH	Substantially Equivalent	Biofire Diagnostics	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 12, 2026	99592	Class II	Ongoing	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-01	Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results	accessdata.fda.gov
June 24, 2026	99261	Class II	Ongoing	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	accessdata.fda.gov
April 22, 2026	98776	Class II	Ongoing	BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.	Contamination to in-vitro diagnostic test may result in false positives.	accessdata.fda.gov
April 1, 2026	98719	Class II	Ongoing	Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485	Respiratory/sore throat panel test may result in false negative results and control failures.	accessdata.fda.gov
October 22, 2025	97870	Class II	Ongoing	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.	accessdata.fda.gov
April 30, 2025	96835	Class II	Ongoing	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.	accessdata.fda.gov
February 27, 2025	96346	Class II	Ongoing	FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374	Increased risk of control failures and false negative test results with multiplexed nucleic acid test.	accessdata.fda.gov
August 7, 2024	95019	Class II	Ongoing	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	accessdata.fda.gov
June 19, 2024	94886	Class II	Ongoing	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.	accessdata.fda.gov
June 10, 2024	94942	Class II	Ongoing	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.	accessdata.fda.gov
May 16, 2024	94992	Class II	Ongoing	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 qualitativ	Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.	accessdata.fda.gov
January 26, 2024	93639	Class II	Ongoing	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.	accessdata.fda.gov
January 26, 2024	93636	Class II	Ongoing	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 me	Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums	accessdata.fda.gov
December 14, 2023	93592	Class II	Ongoing	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.	accessdata.fda.gov
November 27, 2023	93526	Class II	Ongoing	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 addition	accessdata.fda.gov
October 17, 2023	93360	Class II	Ongoing	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 u	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	accessdata.fda.gov
October 17, 2023	93268	Class II	Ongoing	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 diagnos	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 p	accessdata.fda.gov
May 8, 2023	92397	Class II	Ongoing	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.	accessdata.fda.gov
April 25, 2023	92885	Class II	Ongoing	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	accessdata.fda.gov
March 8, 2023	91892	Class II	Ongoing	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.	accessdata.fda.gov
February 1, 2023	91647	Class II	Ongoing	In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147	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.	accessdata.fda.gov
October 11, 2021	88934	Class II	Terminated	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 BACTEC Lytic Anaerobi	Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.	accessdata.fda.gov
July 20, 2021	88410	Class II	Terminated	FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127	Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.	accessdata.fda.gov
June 7, 2021	88117	Class II	Terminated	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)	Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.	accessdata.fda.gov
May 10, 2021	87934	Class II	Terminated	BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338	Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.	accessdata.fda.gov
April 16, 2021	87936	Class II	Terminated	FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144	Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.	accessdata.fda.gov
January 26, 2021	87282	Class II	Terminated	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-ASY-0126 / UDI: 0081	The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.	accessdata.fda.gov
January 22, 2020	85550	Class II	Terminated	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/BACT/ALERT FN Plus 410853/B	There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are availabl	accessdata.fda.gov
August 8, 2019	84825	Class II	Terminated	FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only	Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.	accessdata.fda.gov
March 7, 2019	82354	Class II	Terminated	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/410851; BACT/ALERT FN	Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.	accessdata.fda.gov
March 6, 2019	82338	Class II	Terminated	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 multiplexed nucleic acid-bas	Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.	accessdata.fda.gov
September 10, 2018	81197	Class II	Terminated	-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 RFIT-LBL-0138) which identifies	Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.	accessdata.fda.gov
September 5, 2018	81060	Class II	Terminated	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)/ 00815381020093, when used with t	Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.	accessdata.fda.gov
March 14, 2018	79514	Class II	Terminated	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, Catalog numbers 442020, 4	There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.	accessdata.fda.gov
May 27, 2014	68352	Class II	Terminated	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 designed to test positive bl	BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioMrieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.	accessdata.fda.gov

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Updated October 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.