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BioFire Diagnostics, LLC FDA Recalls
35 recalls on file across devices, 0 of them Class I and 27 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, iClass IIJun 24, 2026Due to increase in false negative results |
| BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.Class IIApr 22, 2026Contamination to in-vitro diagnostic test may result in fa |
| Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485Class IIApr 1, 2026Respiratory/sore throat panel test may result in false nega |
| BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)Class IIOct 22, 2025Due to unintended movement of pouch chemistry, nucleic aci |
| BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systemsClass IIApr 30, 2025Due to manufacturing error, respiratory panel may result in |
| FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374Class IIFeb 27, 2025Increased risk of control failures and false negative test r |
| FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003UClass IIAug 7, 2024Some automated in vitro diagnostic modules and instruments m |
| FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-WClass IIAug 7, 2024Some automated in vitro diagnostic modules and instruments m |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctioClass IIJun 19, 2024If blood culture identification panel is used in conjunction |
| BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144Class IIJun 10, 2024Pneumonia panels have an increased risk of control failures |
| BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143Class IIJun 10, 2024Pneumonia panels have an increased risk of control failures |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GIClass IIMay 16, 2024Due to increase of false positive Vibrio/Vibrio Cholerae res |
| FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microClass IIJan 26, 2024Due to potential signals of increased false positive Norovir |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC PedClass IIJan 26, 2024Due to a trend in false positive Candida tropicalis results |
| FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)Class IIDec 14, 2023Their is a potential for false positive results when using P |
| FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)Class IIDec 14, 2023Their is a potential for false positive results when using P |
| The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIREClass IINov 27, 2023A manufacturing event may contribute to elevated rates of fa |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test iClass IINov 27, 2023A manufacturing event may contribute to elevated rates of fa |
| FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screenClass IIOct 17, 2023Due to an increased risk of degradation of the power entry s |
| BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, InClass IIOct 17, 2023Routine quality control testing of affected blood culture id |
| FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx OnlyClass IIMay 8, 2023Due to manufacturing issue, panels may result in false nega |
| BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx OnlyClass IIMay 8, 2023Due to manufacturing issue, panels may result in false nega |
| FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module SoftwareClass IIApr 25, 2023The firm has identified an increased risk of obtaining false |
| FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)Class IIMar 8, 2023Due to manufacturing issue, Gastrointestinal (GI) Panel may |
| In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742Class IIFeb 1, 2023Due to temperature excursions with products (products being |
| In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116Class IIFeb 1, 2023Due to temperature excursions with products (products being |
| In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147Class IIFeb 1, 2023Due to temperature excursions with products (products being |
| BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog NClass IIOct 11, 2021Due to an increased risk of false positive Acinetobacter cal |
| FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0Class IIJul 20, 2021Due to product complaints received for false negative result |
| FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part NoClass IIJun 7, 2021Due to real-time stability study failures resulting in incre |
| FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)Class IIJun 7, 2021Due to real-time stability study failures resulting in incre |
| BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostiClass IIMay 10, 2021Elevated rates of false negative results may occur when usin |
| FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144Class IIApr 16, 2021Elevated rates of false positive/false negative and control |
| Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCClass IIJan 26, 2021The firm has identified an increased risk of false positive |
| BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FiClass IIJan 26, 2021The firm has identified an increased risk of false positive |