--- title: "BioFire Diagnostics, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search BioFire Diagnostics, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/biofire-diagnostics-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # BioFire Diagnostics, LLC recall records **27** reported ongoing 28 records in this archive. Latest source date Jun 24, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 24, 2026 FDA device enforcement ### [BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic](https://isitonrecall.com/recall/fda-device-z-2936-2026-biofire-respiratory-panel-2-1-rp2-1-ref-423742-udi-code-00815381020529-pcr-based-multiplexed-nucleic/) Due to increase in false negative results Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI. [Official source for BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed n...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2936-2026%22) Apr 22, 2026 FDA device enforcement ### [BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.](https://isitonrecall.com/recall/fda-device-z-2067-2026-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 Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Pol... [Official source for BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2067-2026%22) Apr 1, 2026 FDA device enforcement ### [Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485](https://isitonrecall.com/recall/fda-device-z-2081-2026-biofire-spotfire-respiratory-sore-throat-panel-ref-423485/) Respiratory/sore throat panel test may result in false negative results and control failures. Class II Reported ongoing Distribution: US Nationwide distribution in the states of MS, TX MN, VA. [Official source for Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2081-2026%22) Oct 22, 2025 FDA device enforcement ### [BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)](https://isitonrecall.com/recall/fda-device-z-0602-2026-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 Reported ongoing Distribution: US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None [Official source for BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0602-2026%22) Apr 30, 2025 FDA device enforcement ### [BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems](https://isitonrecall.com/recall/fda-device-z-1877-2025-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 Reported ongoing Distribution: International distribution in the country of Singapore. [Official source for BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1877-2025%22) Feb 27, 2025 FDA device enforcement ### [FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374](https://isitonrecall.com/recall/fda-device-z-1518-2025-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 Reported ongoing Distribution: OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel [Official source for FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1518-2025%22) Aug 7, 2024 FDA device enforcement ### [FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W](https://isitonrecall.com/recall/fda-device-z-3122-2024-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 erroneou... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK,... [Official source for FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3122-2024%22) Aug 7, 2024 FDA device enforcement ### [FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U](https://isitonrecall.com/recall/fda-device-z-3123-2024-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 erroneou... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of NC, TX, OH, CA, KS, AL, WA, NY, PA, IL, WI, KY, LA, NE, FL, UT, IA, SC, VA, AZ, CO, WV, MO, TN, MN, DC, DE, OK,... [Official source for FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3123-2024%22) Jun 19, 2024 FDA device enforcement ### [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: 41...](https://isitonrecall.com/recall/fda-device-z-2456-2024-biofire-blood-culture-identification-2-bcid2-panel-ref-rfit-asy-0147-for-filmarray-systems-when-used/) 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... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC,... [Official source for BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2456-2024%22) Jun 10, 2024 FDA device enforcement ### [BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144](https://isitonrecall.com/recall/fda-device-z-2682-2024-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 Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecua... [Official source for BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2682-2024%22) Jun 10, 2024 FDA device enforcement ### [BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143](https://isitonrecall.com/recall/fda-device-z-2683-2024-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 Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecua... [Official source for BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2683-2024%22) May 16, 2024 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-2514-2024-biofire-filmarray-gastrointestinal-gi-panel-ref-rfit-asy-0116-30-test-kit-biofire-filmarray-gastroin/) Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. Class II Reported ongoing Distribution: U.S.: Nationwide - 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, Pu... [Official source for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY G...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2514-2024%22) Jan 26, 2024 FDA device enforcement ### [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 Ana...](https://isitonrecall.com/recall/fda-device-z-1139-2024-biofire-blood-culture-identification-2-bcid2-panel-when-used-with-bd-bactec-lytic-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 Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,... [Official source for BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic me...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1139-2024%22) Jan 26, 2024 FDA device enforcement ### [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.](https://isitonrecall.com/recall/fda-device-z-1140-2024-filmarray-gastrointestinal-gi-panel-rfit-asy-0116-30-test-kit-rfit-asy-0104-6-test-kit-gastrointesti/) Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, N... [Official source for FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gast...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1140-2024%22) Dec 14, 2023 FDA device enforcement ### [FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)](https://isitonrecall.com/recall/fda-device-z-0993-2024-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 Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ,... [Official source for FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0993-2024%22) Dec 14, 2023 FDA device enforcement ### [FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)](https://isitonrecall.com/recall/fda-device-z-0994-2024-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 Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ,... [Official source for FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0994-2024%22) Nov 27, 2023 FDA device enforcement ### [BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.](https://isitonrecall.com/recall/fda-device-z-0703-2024-biofire-filmarray-gastrointestinal-gi-panel-is-a-qualitative-multiplexed-nucleic-acid-based-in-vitro/) 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 assura... Class II Reported ongoing Distribution: US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD [Official source for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0703-2024%22) Nov 27, 2023 FDA device enforcement ### [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.](https://isitonrecall.com/recall/fda-device-z-0704-2024-the-biofire-respiratory-panel-2-1-rp2-1-is-a-pcr-based-multiplexed-nucleic-acid-test-intended-for-us/) 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 assura... Class II Reported ongoing Distribution: US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD [Official source for The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0704-2024%22) Oct 17, 2023 FDA device enforcement ### [FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioF...](https://isitonrecall.com/recall/fda-device-z-0353-2024-filmarray-torch-ref-htfa-asy-0104-htfa-asy-0104-is-the-biofire-torch-base-which-includes-barcode-sca/) 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 heating inside of the power switch, subseque... Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of 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, N... [Official source for FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0353-2024%22) Oct 17, 2023 FDA device enforcement ### [BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is re...](https://isitonrecall.com/recall/fda-device-z-0451-2024-biofire-blood-culture-identification-2-bcid2-panel-ref-rfit-asy-0147-used-with-maine-molecular-quali/) 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 amplified in some portion of test runs, ... Class II Reported ongoing Distribution: Worldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA, WI, NC,, AK, PA, MN, ND, IN, AR, CO, UT, TX, AL, NJ, MD, SD, LA, OR, MA, ID, NE, MT, VA, IA, MO, WV,... [Official source for BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecul...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0451-2024%22) ## Reasons in these listed records - Due to increase in false negative results - Contamination to in-vitro diagnostic test may result in false positives. - Respiratory/sore throat panel test may result in false negative results and control failures. - Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. These examples come from this result page and are not a ranking of every recall reason. ## Checking BioFire Diagnostics, LLC ### Is there a recall on biofire diagnostics, llc right now? This archive contains 28 records, including 27 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search BioFire Diagnostics, LLC](https://isitonrecall.com/check/?q=BioFire%20Diagnostics%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)