BioFire Diagnostics recalls
21 official recalls and safety alerts involving BioFire Diagnostics since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with BioFire Diagnostics or the relevant agency.
- 2026-08-19
USBioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Due to increase in false negative results
FDA · DeviceBioFire Diagnostics, LLCU.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO,…Official notice →- 2026-05-13
- US
BioFire Diagnostics, LLC recalls Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Respiratory/sore throat panel test may result in false negative results and control failures.
FDA · DeviceBioFire Diagnostics, LLCUS Nationwide distribution in the states of MS, TX MN, VA.Official notice → - US
BioFire Diagnostics, LLC recalls BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Contamination to in-vitro diagnostic test may result in false positives.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the…Official notice → - 2025-12-03
- US
BioFire Diagnostics, LLC recalls 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.
FDA · DeviceBioFire Diagnostics, LLCUS:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: NoneOfficial notice → - 2025-06-04
- US
BioFire Diagnostics, LLC recalls 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.
FDA · DeviceBioFire Diagnostics, LLCInternational distribution in the country of Singapore.Official notice → - 2025-04-16
- US
BioFire Diagnostics, LLC recalls FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
FDA · DeviceBioFire Diagnostics, LLCOUS International Distribution to countries of: France, Italia, Spain,…Official notice → - 2024-09-18
- US
BioFire Diagnostics, LLC recalls 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…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of NC, TX, OH,…Official notice → - 2024-08-28
- US
BioFire Diagnostics, LLC recalls 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.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution in the states of WV, IN, AL and the…Official notice → - 2024-08-14
- US
BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF…
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
FDA · DeviceBioFire Diagnostics, LLCU.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL,…Official notice → - 2024-08-07
- US
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture…
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…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of FL, IL, KY,…Official notice → - 2024-02-21
- US
BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex…
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice → - US
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD…
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2024-02-14
- US
BioFire Diagnostics, LLC recalls 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.
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2024-01-17
- US
BioFire Diagnostics, LLC recalls 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…
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…
FDA · DeviceBioFire Diagnostics, LLCUS: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MDOfficial notice → - 2023-12-13
- US
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI)…
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…
FDA · DeviceBioFire Diagnostics, LLCWorldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA,…Official notice → - 2023-11-29
- US
BioFire Diagnostics, LLC recalls FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB…
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…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2023-09-20
- US
BioFire Diagnostics, LLC recalls FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
FDA · DeviceBioFire Diagnostics, LLCUS:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice → - 2023-08-30
- US
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Due to manufacturing issue, panels may result in false negative results.
FDA · DeviceBioFire Diagnostics, LLCUS: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV…Official notice → - 2023-04-26
- US
BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
FDA · DeviceBioFire Diagnostics, LLCUS Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC,…Official notice → - 2023-03-22
- US
BioFire Diagnostics, LLC recalls In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
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…
FDA · DeviceBioFire Diagnostics, LLCU.S. Nationwide distribution in the states of FL and GA.Official notice → - 2021-12-08
- US
BioFire Diagnostics, LLC recalls BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description:…
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.
FDA · DeviceBioFire Diagnostics, LLCWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice →