BioFire Diagnostics, LLC Recalls
17 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (17)
- Class II
April 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
April 1, 2026
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Respiratory/sore throat panel test may result in false negative results and control failures.
- Class II
October 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 in elevated risk of false negative results and risk of control failures.
- Class II
April 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 failures and/or false negative results.
- Class II
February 27, 2025
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
- Class II
August 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 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.
- Class II
August 7, 2024
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
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.
- Class II
June 19, 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
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.
- Class II
June 10, 2024
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
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.
- Class II
June 10, 2024
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
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.
- Class II
May 16, 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 Gastrointesti
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
- Class II
January 26, 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 B
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
- Class II
January 26, 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.
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
- Class II
December 14, 2023
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
Their is a potential for false positive results when using Pneumonia panel.
- Class II
December 14, 2023
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Their is a potential for false positive results when using Pneumonia panel.
- Class II
November 27, 2023
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
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.
- Class II
November 27, 2023
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 BIOFIRE FILMARRAY Torch Systems.
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.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.