Medical DeviceAug 19, 2026
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based recall — FDA Z-2936-2026
Due to increase in false negative results
Class IIFDA: OngoingBioFire Diagnostics, LLC
Recall history in this database
Classification mix: Class II: 39.
Medical DeviceMay 13, 2026
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit recall — FDA Z-2067-2026
Contamination to in-vitro diagnostic test may result in false positives.
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceDec 3, 2025
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) recall — FDA Z-0602-2026
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 IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceSep 18, 2024
BioFire Diagnostics FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W recall — FDA Z-3122-2024
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceSep 18, 2024
BioFire Diagnostics FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W recall — FDA Z-3123-2024
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceAug 28, 2024
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 recall — FDA Z-2683-2024
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 IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceAug 28, 2024
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 recall — FDA Z-2682-2024
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 IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceAug 14, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE recall — FDA Z-2514-2024
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceAug 7, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY recall — FDA Z-2456-2024
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceFeb 21, 2024
BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) recall — FDA Z-1140-2024
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceFeb 21, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic recall — FDA Z-1139-2024
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceFeb 14, 2024
BioFire Diagnostics FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED recall — FDA Z-0993-2024
Their is a potential for false positive results when using Pneumonia panel.
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceFeb 14, 2024
BioFire Diagnostics FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx recall — FDA Z-0994-2024
Their is a potential for false positive results when using Pneumonia panel.
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceJan 17, 2024
BioFire Diagnostics The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed recall — FDA Z-0704-2024
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceJan 17, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic recall — FDA Z-0703-2024
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceDec 13, 2023
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine recall — FDA Z-0451-2024
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,…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceNov 29, 2023
BioFire Diagnostics FilmArray TORCH REF HTFA-ASY-0104 recall — FDA Z-0353-2024
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceSep 20, 2023
BioFire Diagnostics FILMARRAY Gastrointestinal (GI) Panel recall — FDA Z-2588-2023
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceAug 30, 2023
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only recall — FDA Z-2439-2023
Due to manufacturing issue, panels may result in false negative results.
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceAug 30, 2023
BioFire Diagnostics FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY recall — FDA Z-2440-2023
Due to manufacturing issue, panels may result in false negative results.
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceApr 26, 2023
BioFire Diagnostics FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF recall — FDA Z-1392-2023
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceMar 22, 2023
BioFire Diagnostics In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 recall — FDA Z-1251-2023
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceMar 22, 2023
BioFire Diagnostics In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) recall — FDA Z-1252-2023
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Medical DeviceMar 22, 2023
BioFire Diagnostics In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 recall — FDA Z-1253-2023
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…
Class IIFDA: OngoingBioFire Diagnostics, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies BioFire Diagnostics, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.