Brand

Biofire Diagnostics, Llc Recalls

25 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Biofire Diagnostics, Llc.

25Total Recalls
1Critical
653,195Units Affected
Apr 22, 2026Most Recent
All Recalls

Every Biofire Diagnostics, Llc Recall

Sorted by most recent. Click any recall for full details.

25 recalls
High RiskFDA
Biofire Diagnostics, Llc
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Diagnostic Devices·106 affected·Apr 22, 2026
High RiskFDA
Biofire Diagnostics, Llc
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Respiratory Devices·30 affected·Apr 30, 2025
High RiskFDA
Biofire Diagnostics, Llc
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Medical Devices·29 affected·Feb 27, 2025
High RiskFDA
Biofire Diagnostics, Llc
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
Medical Devices·1,001 affected·Aug 7, 2024
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Me...
Medical Devices·99,822 affected·Jun 19, 2024
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Medical Devices·24 affected·Jun 10, 2024
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Medical Devices·58 affected·Jun 10, 2024
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-...
Diagnostic Devices·67,613 affected·May 16, 2024
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiple...
Diagnostic Devices·64,594 affected·Jan 26, 2024
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
Diagnostic Devices·214,080 affected·Dec 14, 2023
High RiskFDA
Biofire Diagnostics, Llc
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...
Respiratory Devices·57 affected·Nov 27, 2023
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArr...
Medical Devices·32,910 affected·Oct 17, 2023
High RiskFDA
Biofire Diagnostics, Llc
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Respiratory Devices·705 affected·May 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Medical Devices·24 affected·May 8, 2023
CriticalFDA
Biofire Diagnostics, Llc
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Medical Devices·61,069 affected·Apr 25, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Medical Devices·900 affected·Mar 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Diagnostic Devices·2 affected·Feb 1, 2023
High RiskFDA
Biofire Diagnostics, Llc
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 4...
Medical Devices·14,140 affected·Oct 11, 2021
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Medical Devices·9 affected·Apr 16, 2021
High RiskFDA
Biofire Diagnostics, Llc
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Produc...
Medical Devices·21,922 affected·Jan 26, 2021
High RiskFDA
Biofire Diagnostics, Llc
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle ...
Diagnostic Devices·18,501 affected·Jan 22, 2020
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Medical Devices·23 affected·Aug 8, 2019
High RiskFDA
Biofire Diagnostics, Llc
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood cult...
Diagnostic Devices·20,350 affected·Mar 7, 2019
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage...
Diagnostic Devices·17,188 affected·Mar 6, 2019
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 te...
Diagnostic Devices·18,038 affected·Sep 5, 2018