fda
31 records
FDA Device Recall: BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
2025-06-04
Class II — Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
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FDA Device Recall: FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
2025-04-16
Class II — Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
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FDA Recall: BioFire Diagnostics, LLC — Class II
20240828
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 | Product: BIOFIRE FILMARRAY Pneumonia Panel plus...
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FDA Recall: BioFire Diagnostics, LLC — Class II
20240221
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. | Product: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-A...
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FDA Recall: BioFire Diagnostics, LLC — Class II
20240214
Their is a potential for false positive results when using Pneumonia panel. | Product: FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit
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FDA Recall: BioFire Diagnostics, LLC — Class II
20240117
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could | Product: The BIOFIRE Respiratory Panel 2.1 (RP2...
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FDA Device Recall: FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
2024-09-18
Class II — 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 instrumen...
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FDA Device Recall: BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
2024-08-28
Class II — 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.
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FDA Device Recall: BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
2024-08-28
Class II — 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.
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FDA Device Recall: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit)
2024-08-14
Class II — Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
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FDA Device Recall: BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FI
2024-08-07
Class II — 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 leve...
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FDA Device Recall: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-010
2024-02-21
Class II — Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
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FDA Device Recall: FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD,
2024-02-14
Class II — Their is a potential for false positive results when using Pneumonia panel.
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FDA Device Recall: The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic aci
2024-01-17
Class II — 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 treat...
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FDA Device Recall: BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used w
2023-12-13
Class II — 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, th...
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FDA Device Recall: FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116)
2023-09-20
Class II — The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
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FDA Device Recall: BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD,
2023-08-30
Class II — Due to manufacturing issue, panels may result in false negative results.
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FDA Device Recall: FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, C
2023-08-30
Class II — Due to manufacturing issue, panels may result in false negative results.
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FDA Device Recall: FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116,
2023-04-26
Class II — Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
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FDA Device Recall: In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
2023-03-22
Class II — 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 ...
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FDA Device Recall: BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI:
2021-12-08
Class II — 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.
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FDA Device Recall: FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
2021-06-30
Class II — Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
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FDA Device Recall: Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Cult
2021-03-10
Class II — The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
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FDA Device Recall: BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 -
2021-03-10
Class II — The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
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FDA Device Recall: FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086
2020-06-17
Class II — There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjuncti...
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FDA Device Recall: FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)
2020-03-18
Class II — Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being p...
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FDA Recall: BioFire Diagnostics, LLC — Class II
20190424
Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain bl | Product: FilmArray BCID Panel, IVD, Rx Only, Bi...
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FDA Device Recall: FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC
2019-05-08
Class II — Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
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FDA Device Recall: FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, an
2019-04-24
Class II — Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
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FDA Device Recall: FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostic
2018-11-07
Class II — Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
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FDA Device Recall: FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray
2014-07-02
Class II — BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux BacT/ALERT Standard Anaerobic (SN) bl...
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ny_corps
1 records
NY Corp: BIOFIRE DIAGNOSTICS, LLC
2014-08-11
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Delaware
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USASpending
1 records
Federal Award: BIOFIRE DIAGNOSTICS LLC — $1,314,390
2016-12-20
BIOFIRE DIAGNOSTICS INC:1109738 [17-002148]
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