BioFire Diagnostics, LLC

FDA recalling firm · 33 enforcement events · 43 product records · 2018–2026 · UT

BioFire Diagnostics, LLC has 33 FDA enforcement events on this register (43 product records) between 2018 and 2026: 33 device; the busiest year was 2023 with 8.

0% of its events are Class I; the most common class is Class II (33). 20 events are listed as ongoing; the recalling firm's address is in UT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
24 Jun 2026	BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic	Device	Class II	1	Ongoing
22 Apr 2026	BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.	Device	Class II	1	Ongoing
1 Apr 2026	Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485	Device	Class II	1	Ongoing
22 Oct 2025	BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)	Device	Class II	1	Ongoing
30 Apr 2025	BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems	Device	Class II	1	Ongoing
27 Feb 2025	FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374	Device	Class II	1	Ongoing
7 Aug 2024	FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W	Device	Class II	2	Ongoing
19 Jun 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	Device	Class II	1	Ongoing
10 Jun 2024	BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144	Device	Class II	2	Ongoing
16 May 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¿…	Device	Class II	1	Ongoing
26 Jan 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…	Device	Class II	1	Ongoing
26 Jan 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.	Device	Class II	1	Ongoing
14 Dec 2023	FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)	Device	Class II	2	Ongoing
27 Nov 2023	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.	Device	Class II	2	Ongoing
17 Oct 2023	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.…	Device	Class II	1	Ongoing
17 Oct 2023	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	Device	Class II	1	Ongoing
8 May 2023	BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only	Device	Class II	2	Ongoing
25 Apr 2023	FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software	Device	Class II	1	Ongoing
8 Mar 2023	FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)	Device	Class II	1	Ongoing
1 Feb 2023	In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147	Device	Class II	3	Ongoing
11 Oct 2021	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 Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC…	Device	Class II	1	Terminated
20 Jul 2021	FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127	Device	Class II	1	Terminated
7 Jun 2021	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)	Device	Class II	2	Terminated
10 May 2021	BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338	Device	Class II	1	Terminated
16 Apr 2021	FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144	Device	Class II	1	Terminated
26 Jan 2021	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: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only	Device	Class II	2	Terminated
22 Jan 2020	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/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Product Usage: is a qualitative multiplexed nucleic…	Device	Class II	2	Terminated
8 Aug 2019	FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only	Device	Class II	1	Terminated
7 Mar 2019	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 Plus/410852; BACT/ALERT PF Plus/410853	Device	Class II	1	Terminated
6 Mar 2019	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-based in vitro diagnostic test intended for use with FilmArray systems.	Device	Class II	1	Terminated
10 Sep 2018	-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 the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray…	Device	Class II	1	Terminated
5 Sep 2018	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 the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851,…	Device	Class II	1	Terminated
14 Mar 2018	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, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.	Device	Class II	1	Terminated

By type and class

Device33

Class II33

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for BioFire Diagnostics, LLC by year initiated.

Questions and answers

How many FDA recalls has BioFire Diagnostics, LLC had?

33 enforcement events (43 product records) on this register, 2018–2026: 33 device.

Are any BioFire Diagnostics, LLC recalls ongoing?

20 events are listed as ongoing in the current openFDA export.

What class are BioFire Diagnostics, LLC recalls?

33 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.