BioFire Diagnostics, LLC

Complete recall history across all FDA and CPSC categories — 40 total recalls

BioFire Diagnostics, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (40)

FDA medical device enforcement actions by BioFire Diagnostics, LLC

Date Product Reason Class
Apr 22, 2026 BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. Contamination to in-vitro diagnostic test may result in false positives. Class II
Apr 1, 2026 Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 Respiratory/sore throat panel test may result in false negative results and ... Class II
Oct 22, 2025 BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) Due to unintended movement of pouch chemistry, nucleic acid test may result... Class II
Apr 30, 2025 BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems Due to manufacturing error, respiratory panel may result in elevated control ... Class II
Feb 27, 2025 FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Increased risk of control failures and false negative test results with multi... Class II
Aug 7, 2024 FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U Some automated in vitro diagnostic modules and instruments manufactured or se... Class II
Aug 7, 2024 FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W Some automated in vitro diagnostic modules and instruments manufactured or se... Class II
Jun 19, 2024 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for... If blood culture identification panel is used in conjunction with specific lo... Class II
Jun 10, 2024 BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 Pneumonia panels have an increased risk of control failures due to an issue i... Class II
Jun 10, 2024 BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 Pneumonia panels have an increased risk of control failures due to an issue i... Class II
May 16, 2024 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit... Due to increase of false positive Vibrio/Vibrio Cholerae results when using a... Class II
Jan 26, 2024 BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD B... Due to a trend in false positive Candida tropicalis results on blood culture ... Class II
Jan 26, 2024 FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-... Due to potential signals of increased false positive Norovirus results when u... Class II
Dec 14, 2023 FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only... Their is a potential for false positive results when using Pneumonia panel. Class II
Dec 14, 2023 FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IV... Their is a potential for false positive results when using Pneumonia panel. Class II
Nov 27, 2023 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nu... A manufacturing event may contribute to elevated rates of false negative resu... Class II
Nov 27, 2023 The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic ... A manufacturing event may contribute to elevated rates of false negative resu... Class II
Oct 17, 2023 FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base w... Due to an increased risk of degradation of the power entry switch resulting f... Class II
Oct 17, 2023 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, use... Routine quality control testing of affected blood culture identification pane... Class II
May 8, 2023 FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems... Due to manufacturing issue, panels may result in false negative results. Class II
May 8, 2023 BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IV... Due to manufacturing issue, panels may result in false negative results. Class II
Apr 25, 2023 FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-011... The firm has identified an increased risk of obtaining false positive Cryptos... Class II
Mar 8, 2023 FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-01... Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false ... Class II
Feb 1, 2023 In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 Due to temperature excursions with products (products being stored outside of... Class II
Feb 1, 2023 In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - RE... Due to temperature excursions with products (products being stored outside of... Class II
Feb 1, 2023 In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 Due to temperature excursions with products (products being stored outside of... Class II
Oct 11, 2021 BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 U... Due to an increased risk of false positive Acinetobacter calcoaceticus- bauma... Class II
Jul 20, 2021 FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: ... Due to product complaints received for false negative results (dropouts) with... Class II
Jun 7, 2021 FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-A... Due to real-time stability study failures resulting in increase rate of false... Class II
Jun 7, 2021 FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 /... Due to real-time stability study failures resulting in increase rate of false... Class II
May 10, 2021 BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Cult... Elevated rates of false negative results may occur when using blood culture p... Class II
Apr 16, 2021 FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 Elevated rates of false positive/false negative and control failures while us... Class II
Jan 26, 2021 BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 0081538102033... The firm has identified an increased risk of false positive Pseudomonas aerug... Class II
Jan 26, 2021 Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood C... The firm has identified an increased risk of false positive Pseudomonas aerug... Class II
Jan 22, 2020 FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 008153810200... There is an increased risk of false positive Proteus results when using the F... Class II
Jan 22, 2020 FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020... There is an increased risk of false positive Proteus results when using the F... Class II
Aug 8, 2019 FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (... Complaints have been received concerning elevated rates of false negative res... Class II
Mar 7, 2019 FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126,... Increased risk of false positive Enterobacteriaceae and Escherichia coli resu... Class II
Mar 6, 2019 FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC... Elevated rates of false positive results for Campylobacter and Cryptosporidiu... Class II
Sep 10, 2018 -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) ... Firm identified an issue in the manufacturing process which might contribute ... Class II
Sep 5, 2018 FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnos... Increased risk of false positive results for Proteus when the product is used... Class II
Mar 14, 2018 FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RF... There is an increased risk of false positive Proteus results when the product... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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