Is this your brand? Sign in to claim ownership.

BioFire Diagnostics, LLC

Last updated September 17, 2026

Information

Country: US
Address: 515 Colorow Drive, Salt Lake City, UT, 84108
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3002773840
DUNS Number: —

Catalogue (83)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
FilmArray® 2.0 Instrument	FLM2-ASY-0001	FDA UDI	Class II	Active
BioFire® Joint Infection (JI) Panel	RFIT-ASY-0138	FDA UDI	Class II	Active
FilmArray® Instrument	FLM1-ASY-0001	FDA UDI	Class II	Unknown
BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid	425089	FDA UDI	Class II	Active
FilmArray® Pneumonia Panel plus (Pneumoplus)	RFIT-ASY-0143	FDA UDI	Class II	Active
BIOFIRE ® SPOTFIRE ® Module	FAST-ASY-0002	FDA UDI	Class II	Active
BIOFIRE ® SPOTFIRE ® Control Station	FAST-ASY-0001-W	FDA UDI	Class II	Active
FilmArray® Gastrointestinal (GI) Panel	RFIT-ASY-0104	FDA UDI	Class II	Active
FilmArray® Respiratory Panel 2 (RP2)	RFIT-ASY-0129	FDA UDI	Class II	Unknown
FilmArray® Pneumonia Panel (Pneumo)	RFIT-ASY-0145	FDA UDI	Class II	Active
FilmArray® Pneumonia Panel (Pneumo)	RFIT-ASY-0144	FDA UDI	Class II	Active
FilmArray® Respiratory Panel 2 (RP2)	RFIT-ASY-0130	FDA UDI	Class II	Unknown
BIOFIRE® FILMARRAY® Tropical Fever Panel	424803	FDA UDI	Class II	Active
BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests	423883	FDA UDI	N	Active
FilmArray® Respiratory Panel (RP)	RFIT-ASY-0124	FDA UDI	Class II	Unknown
FilmArray® Meningitis/Encephalitis (ME) Panel	RFIT-ASY-0118	FDA UDI	Class II	Active
BioFire® Blood Culture Identification 2 (BCID2) Panel	RFIT-ASY-0148	FDA UDI	Class II	Active
FilmArray® BCID Panel	RFIT-ASY-0126	FDA UDI	Class II	Unknown
FilmArray® Gastrointestinal (GI) Panel	RFIT-ASY-0116	FDA UDI	Class II	Active
FilmArray® Respiratory Panel 2 plus (RP2plus)	RFIT-ASY-0137	FDA UDI	Class II	Unknown
BioFire® Blood Culture Identification 2 (BCID2) Panel	RFIT-ASY-0147	FDA UDI	Class II	Active
BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini	424537	FDA UDI	Class II	Active
FilmArray® Torch Module	HTFA-ASY-0003-W	FDA UDI	Class II	Active
FilmArray® Instrument	FLM1-ASY-0001	FDA UDI	Class II	Unknown
BIOFIRE ® SPOTFIRE ® Module	FAST-ASY-0002-W	FDA UDI	Class II	Active
BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel	423485	FDA UDI	Class II	Active
FilmArray® 2.0 Instrument	FLM2-ASY-0001	FDA UDI	Class II	Unknown
FilmArray® 2.0 Instrument	FLM2-ASY-0001-W	FDA UDI	Class II	Active
BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid	424898	FDA UDI	Class II	Active
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini	424589	FDA UDI	Class II	Active
FilmArray® Torch Module	HTFA-SUB-0103	FDA UDI	Class II	Active
FilmArray® Torch System Base	HTFA-ASY-0001-W	FDA UDI	Class II	Active
FilmArray® Respiratory Panel (RP)	RFIT-ASY-0125	FDA UDI	Class II	Unknown
FilmArray® BCID Panel	RFIT-ASY-0127	FDA UDI	Class II	Unknown
FilmArray® Meningitis/Encephalitis (ME) Panel	RFIT-ASY-0119	FDA UDI	Class II	Active
FilmArray® Torch System Base	HTFA-ASY-0104	FDA UDI	Class II	Active
BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel	424461	FDA UDI	Class II	Active
FilmArray® Pneumonia Panel plus (Pneumoplus)	RFIT-ASY-0142	FDA UDI	Class II	Active
BioFire® Respiratory Panel 2.1 EUA	423738	FDA UDI	N	Unknown
BioFire® Respiratory Panel 2.1	423742	FDA UDI	Class II	Active
FilmArray® Respiratory Panel 2 plus (RP2plus)	RFIT-ASY-0136	FDA UDI	Class II	Unknown
FilmArray® Respiratory Panel (RP) EZ	RFIT-ASY-0120	FDA UDI	Class II	Unknown
BioFire® Joint Infection (JI) Panel	RFIT-ASY-0135	FDA UDI	Class II	Active
BIOFIRE ® SPOTFIRE ® Control Station	FAST-ASY-0001	FDA UDI	Class II	Active
FilmArray® Torch System Base	HTFA-ASY-0104	FDA UDI	Class II	Unknown
FilmArray® Torch Module	HTFA-SUB-0103	FDA UDI	Class II	Unknown
Filmarray Blood Culture Identification (bcid) Panel	K130914	FDA 510(k)	Class II	Active
FilmArray Respiratory Panel (RP) for use with FilmArray Torch	K160068	FDA 510(k)	Class II	Active
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini	K230719	FDA 510(k)	Class II	Active
FilmArray Pneumonia Panel plus	K222601	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (43)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 22, 2026	Z-2067-2026	—	open, classified	Contamination to in-vitro diagnostic test may result in false positives.
Apr 1, 2026	Z-2081-2026	—	open, classified	Respiratory/sore throat panel test may result in false negative results and control failures.
Oct 22, 2025	Z-0602-2026	—	open, classified	Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Apr 30, 2025	Z-1877-2025	—	open, classified	Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Feb 27, 2025	Z-1518-2025	—	open, classified	Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Aug 7, 2024	Z-3123-2024	—	open, classified	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.
Aug 7, 2024	Z-3122-2024	—	open, classified	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.
Jun 19, 2024	Z-2456-2024	—	open, classified	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.
Jun 10, 2024	Z-2683-2024	—	open, classified	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.
Jun 10, 2024	Z-2682-2024	—	open, classified	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.
May 16, 2024	Z-2514-2024	—	open, classified	Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Jan 26, 2024	Z-1139-2024	—	open, classified	Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
Jan 26, 2024	Z-1140-2024	—	open, classified	Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
Dec 14, 2023	Z-0994-2024	—	open, classified	Their is a potential for false positive results when using Pneumonia panel.
Dec 14, 2023	Z-0993-2024	—	open, classified	Their is a potential for false positive results when using Pneumonia panel.
Nov 27, 2023	Z-0704-2024	—	open, classified	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.
Nov 27, 2023	Z-0703-2024	—	open, classified	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.
Oct 17, 2023	Z-0451-2024	—	open, classified	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.
Oct 17, 2023	Z-0353-2024	—	open, classified	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.
May 8, 2023	Z-2439-2023	—	open, classified	Due to manufacturing issue, panels may result in false negative results.
May 8, 2023	Z-2440-2023	—	open, classified	Due to manufacturing issue, panels may result in false negative results.
Apr 25, 2023	Z-2588-2023	—	open, classified	The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Mar 8, 2023	Z-1392-2023	—	open, classified	Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Feb 1, 2023	Z-1253-2023	—	open, classified	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.
Feb 1, 2023	Z-1251-2023	—	open, classified	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.
Feb 1, 2023	Z-1252-2023	—	open, classified	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.
Oct 11, 2021	Z-0312-2022	—	terminated	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.
Jul 20, 2021	Z-2245-2021	—	terminated	Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Jun 7, 2021	Z-2039-2021	—	terminated	Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
Jun 7, 2021	Z-2040-2021	—	terminated	Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
May 10, 2021	Z-1903-2021	—	terminated	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.
Apr 16, 2021	Z-1944-2021	—	terminated	Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Jan 26, 2021	Z-1157-2021	—	terminated	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.
Jan 26, 2021	Z-1158-2021	—	terminated	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.
Jan 22, 2020	Z-2295-2020	—	terminated	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 available (within 24-48 hours).
Jan 22, 2020	Z-2296-2020	—	terminated	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 available (within 24-48 hours).
Aug 8, 2019	Z-1451-2020	—	terminated	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.
Mar 7, 2019	Z-1133-2019	—	terminated	Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
Mar 6, 2019	Z-1242-2019	—	terminated	Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
Sep 10, 2018	Z-0446-2019	—	terminated	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.
Sep 5, 2018	Z-0296-2019	—	terminated	Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
Mar 14, 2018	Z-1513-2018	—	terminated	There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
May 27, 2014	Z-1843-2014	—	terminated	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.