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BioFire Diagnostics Recalls
44 recalls on record · July 2, 2014 to August 19, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 14, 2021Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No
Hazard: Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
June 30, 2021Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Hazard: Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
June 30, 2021Medical DevicesFDA
BioFire Diagnostics, LLC recalls BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnosti
Hazard: Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
March 10, 2021Medical DevicesFDA
BioFire Diagnostics, LLC recalls BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with Fi
Hazard: 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.
March 10, 2021Medical DevicesFDA
BioFire Diagnostics, LLC recalls Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BC
Hazard: 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.
June 17, 2020Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood
Hazard: 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 conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
June 17, 2020Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Bloo
Hazard: 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 conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
March 18, 2020Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Hazard: 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 provided which could potentially lead to more serious health events.
May 8, 2019Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116),
Hazard: Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
April 24, 2019Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the fol
Hazard: Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
November 21, 2018Medical DevicesFDA
BioFire Diagnostics, LLC recalls -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray
Hazard: Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
November 7, 2018Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFI
Hazard: Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
May 2, 2018Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127
Hazard: There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
July 2, 2014Medical DevicesFDA
BioFire Diagnostics, Inc. recalls FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Pane
Hazard: 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) blood culture bottles. False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.