Biofire Diagnostics recalls
Biofire Diagnostics appears in 47 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 47 |
|---|---|
| Published | 2014-07-02 to 2026-10-21 |
| By agency | FDA Device (47) |
| By classification | Class II (47) |
| By status | ongoing (30), terminated (17) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), R…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics
Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results - Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics
Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results - Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30…
FDA Device · Class II · 2026-10-21 · Biofire Diagnostics
Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results - BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
FDA Device · Class II · 2026-08-19 · Biofire Diagnostics
Reason: Due to increase in false negative results - BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics
Reason: Contamination to in-vitro diagnostic test may result in false positives. - Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
FDA Device · Class II · 2026-05-13 · Biofire Diagnostics
Reason: Respiratory/sore throat panel test may result in false negative results and control failures. - BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
FDA Device · Class II · 2025-12-03 · Biofire Diagnostics
Reason: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. - BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
FDA Device · Class II · 2025-06-04 · Biofire Diagnostics
Reason: Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. - FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
FDA Device · Class II · 2025-04-16 · Biofire Diagnostics
Reason: Increased risk of control failures and false negative test results with multiplexed nucleic acid test. - FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
FDA Device · Class II · 2024-09-18 · Biofire Diagnostics
Reason: 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 te… - FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
FDA Device · Class II · 2024-09-18 · Biofire Diagnostics
Reason: 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 te… - BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
FDA Device · Class II · 2024-08-28 · Biofire Diagnostics
Reason: 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. - BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
FDA Device · Class II · 2024-08-28 · Biofire Diagnostics
Reason: 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. - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-01…
FDA Device · Class II · 2024-08-14 · Biofire Diagnostics
Reason: Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. - BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Medi…
FDA Device · Class II · 2024-08-07 · Biofire Diagnostics
Reason: 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… - BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC…
FDA Device · Class II · 2024-02-21 · Biofire Diagnostics
Reason: Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums - FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucle…
FDA Device · Class II · 2024-02-21 · Biofire Diagnostics
Reason: Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. - FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
FDA Device · Class II · 2024-02-14 · Biofire Diagnostics
Reason: Their is a potential for false positive results when using Pneumonia panel. - FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
FDA Device · Class II · 2024-02-14 · Biofire Diagnostics
Reason: Their is a potential for false positive results when using Pneumonia panel. - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use wit…
FDA Device · Class II · 2024-01-17 · Biofire Diagnostics
Reason: 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 t… - The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or B…
FDA Device · Class II · 2024-01-17 · Biofire Diagnostics
Reason: 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 t… - BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray…
FDA Device · Class II · 2023-12-13 · Biofire Diagnostics
Reason: 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 am… - FilmArray TORCH REF HTFA-ASY-0104
FDA Device · Class II · 2023-11-29 · Biofire Diagnostics
Reason: 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 heatin… - FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
FDA Device · Class II · 2023-09-20 · Biofire Diagnostics
Reason: The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel - BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
FDA Device · Class II · 2023-08-30 · Biofire Diagnostics
Reason: Due to manufacturing issue, panels may result in false negative results. - FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
FDA Device · Class II · 2023-08-30 · Biofire Diagnostics
Reason: Due to manufacturing issue, panels may result in false negative results. - FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
FDA Device · Class II · 2023-04-26 · Biofire Diagnostics
Reason: Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. - In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics
Reason: 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 del… - In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics
Reason: 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 del… - In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
FDA Device · Class II · 2023-03-22 · Biofire Diagnostics
Reason: 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 del… - BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 4420…
FDA Device · Class II · 2021-12-08 · Biofire Diagnostics
Reason: 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. - FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
FDA Device · Class II · 2021-08-18 · Biofire Diagnostics
Reason: Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error. - FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142…
FDA Device · Class II · 2021-07-14 · Biofire Diagnostics
Reason: Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. - FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 0…
FDA Device · Class II · 2021-07-14 · Biofire Diagnostics
Reason: Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. - FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
FDA Device · Class II · 2021-06-30 · Biofire Diagnostics
Reason: Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process. - BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (0…
FDA Device · Class II · 2021-06-30 · Biofire Diagnostics
Reason: 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 OP… - BioFire BCID2 Panel
FDA Device · Class II · 2021-03-10 · Biofire Diagnostics
Reason: 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. - Gram-Negative Bacteria And Associated Resistance Markers
FDA Device · Class II · 2021-03-10 · Biofire Diagnostics
Reason: 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. - FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Cata…
FDA Device · Class II · 2020-06-17 · Biofire Diagnostics
Reason: 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.… - FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catal…
FDA Device · Class II · 2020-06-17 · Biofire Diagnostics
Reason: 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.… - FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
FDA Device · Class II · 2020-03-18 · Biofire Diagnostics
Reason: 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 potentiall… - FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The Fi…
FDA Device · Class II · 2019-05-08 · Biofire Diagnostics
Reason: Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. - FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture…
FDA Device · Class II · 2019-04-24 · Biofire Diagnostics
Reason: Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles. - -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (…
FDA Device · Class II · 2018-11-21 · Biofire Diagnostics
Reason: 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. - FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test k…
FDA Device · Class II · 2018-11-07 · Biofire Diagnostics
Reason: Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles. - FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when…
FDA Device · Class II · 2018-05-02 · Biofire Diagnostics
Reason: There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles. - FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative mul…
FDA Device · Class II · 2014-07-02 · Biofire Diagnostics
Reason: BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles. False pos…