BioFire® FilmArray® Support –
Product Labeling

Here you will find technical notes, references, manuals and other support items for the commercial BioFire FilmArray System and Panels. For DOD specific documents or if you do not find what you are looking for, please contact our Technical Support Team.

Emergency Use Authorizations - Product Labeling

FilmArray BioThreat-E Test (EUA)

FilmArray BioThreat-E Test (EUA) Instructions for Use and Quick Guides
Instructions for Use
Quick Guide
Fact Sheets
Healthcare Provider
Patient
FilmArray BioThreat-E Test (EUA) Software Module
Pouch Module Installation Guide
Technical Notes
Guidelines for Laboratory Verification of Performance of the FilmArray BioThreat-E
Sources of External Control Materials for the FilmArray BioThreat-E Test
BioThreat-E Kit Report Form
BioThreat-E Report Form

BioFire COVID-19 Test (EUA)

US FDA Documentation – EUA

The EUA (Emergency Use Authorization) for the BioFire COVID-19 Test enables CLIA moderate and high complexity laboratories to conduct a PCR test for SARS-CoV-2 in-house, providing results in approximately one hour.

Fact Sheets
Instructions for Use and Quick Guides
BioFire COVID-19 Test – Version 1.1

IFU and Quick Guides Updated: May 2022

BIOFIRE® SHIELD™ Control Kit for the BioFire COVID-19 Test v1.1

IFU Updated: May 2022; Quick Guide Updated: June 2021 

Software Modules for BioFire COVID-19 Test – Version 1.1
BioFire COVID-19 Test v 1.1 Pouch Module Download Form (Updated May 2022)

BioFire COVID-19 Test v1.1 ERM Software Download Form (Released September 2022)

Technical Notes
BioFire COVID-19 Test Report Form
BioFire COVID-19 Test Report Form

IVD - For in vitro Diagnostic Use Panels - Product Labeling

BioFire Global Fever Panel

BioFire Global Fever Panel Instructions for Use and Quick Guides
Instructions for Use
Quick Guide
BIOFIRE® SHIELD Control Kit for the BioFire Global Fever Panel Instructions for Use and Quick Guides
Instructions for Use
Quick Guide
Technical Notes
Interim Guidelines for Laboratory Verification of Performance of the BioFire Global Fever Panel

Installing the BioFire Global Fever Panel Pouch Module on BioFire FilmArray Systems

BioFire Global Fever Special Pathogens Panel

BioFire Global Fever Special Pathogens Panel Instructions for Use and Quick Guides
Instructions for Use
Quick Guide
BIOFIRE® SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel Instructions for Use and Quick Guides
Instructions for Use
Quick Guide
Technical Notes
Protocols for Laboratory Verification of Performance of the BioFire Global Fever Special Pathogens Panel Technical Note

Not for Diagnostic Use Panels - Product Labeling

BioFire Defense FilmArray Panels

FilmArray BioThreat Panel

FilmArray BioThreat Panel Quick Guide
Instructions for Use
Quick Guide

FilmArray Global Fever Panel - RUO

FilmArray Global Fever Panel – RUO Instructions for Use and Quick Guides
Instructions for Use
Quick Guide
Software Module
FilmArray Global Fever Panel RUO v1.1 Pouch Module v2.1.1 Download Form (Updated December 2022)

FilmArray Food & Water Panel

FilmArray Food & Water Panel – Instructions for Use and Quick Guides
Instructions for Use
Quick Guide

Customer Advisory Notice

BCID2 Panel (FSCA 5811)

ADVISORY NOTICE URGENT: MEDICAL DEVICE RECALL bioMérieux FSCA 5811 – Increased Risk of False Positive Candida tropicalis Results using BIOFIRE® Blood Culture Identification 2 (BCID2) Panel (Part No.: RFIT-ASY-0147) with BD BACTEC Blood Culture Vials Click to view Acknowledgment Form

GI Panel (FSCA 5812)

ADVISORY NOTICE URGENT: MEDICAL DEVICE RECALL (bioMérieux FSCA 5812) Increased Risk of False Positive Norovirus Results with the BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel (RFIT-ASY-0116 and RFIT-ASY-0104) Click to view Acknowledgment Form

Pneumonia Panel (FSCA 5790)

URGENT: Medical Device Correction (bioMérieux FSCA 5790)
Increased risk of false positive seasonal Coronavirus results using the BIOFIRE® FILMARRAY® Pneumonia Panel and BIOFIRE® FILMARRAY® Pneumonia (PNplus) Panel plus
Click to view Acknowledgment Form

BioFire FilmArray Torch (FSCA 5761)

ADVISORY NOTICE URGENT: MEDICAL DEVICE CORRECTION (bioMérieux FSCA 5761) Increased Risk of Power Short with the BIOFIRE® FILMARRAY® TORCH System Click to view Acknowledgment Form

BCID2 Panel (FSCA 5788)

ADVISORY NOTICE URGENT: Medical Device Correction (bioMérieux FSCA 5788)
Potential for Candida tropicalis ‘Not Detected’ results when testing the MMQCI FilmArray BCID2 Control Panel M416 with the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel
Click to view Acknowledgment Form

Additional Support Documents

Safety Data Sheets

Product Warranty Documents