FDA recall record · openFDA

BioFire Diagnostics, LLC

26 FDA recalls on record (2023–2026) — 26 device. 26 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to temperature excursions with products (products being stored outside of the required temperature specifications) t 3

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and 2

Their is a potential for false positive results when using Pneumonia panel. 2

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could le 2

Due to manufacturing issue, panels may result in false negative results. 2

Recalls

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. Class II 2026-04-22 Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 Class II 2026-04-01 BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems Class II 2025-04-30 FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Class II 2025-02-27 BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) Class II 2025-10-22 FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal micro Class II 2024-01-26 BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 Class II 2024-06-10 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctio Class II 2024-06-19 BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 Class II 2024-06-10 FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W Class II 2024-08-07 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI Class II 2024-05-16 FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U Class II 2024-08-07 BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Ped Class II 2024-01-26 The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE Class II 2023-11-27 FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) Class II 2023-12-14 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In Class II 2023-10-17 FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software Class II 2023-04-25 BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only Class II 2023-05-08 FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) Class II 2023-03-08 In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 Class II 2023-02-01 FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only Class II 2023-05-08 FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) Class II 2023-12-14 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test i Class II 2023-11-27 FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen Class II 2023-10-17 In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742 Class II 2023-02-01 In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 Class II 2023-02-01

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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