FilmArray® Support – Product Labeling

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

Emergency Use Authorizations - Product Labeling

BioFire COVID-19 Test (EUA)

Instructions for Use and Quick Guides
BioFire COVID-19 Test – Version 1.1 (Revision 5) BioFire COVID-19 Test – Version 1.1 (Revision 6)

 

BioFire COVID-19 Test External Control Kit for the BioFire COVID-19 Test v1.0   BIOFIRE® SHIELD™ Control Kit for the BioFire COVID-19 Test v1.1

 

Health Canada Documentation
Date of Issuance: May 4, 2020

Authorized for use in Canada in accordance with the Interim Order Respecting the Importation and Sale of Medical Devices in relation to COVID-19

Interim Order No. 314097

 

Software Module
BioFire COVID-19 Test Pouch Module Installation Instructions
BioFire COVID-19 Pouch Module Download Form

 

Technical Notes
Biosafety when Testing Suspected SARS-CoV-2 Samples on the BioFire® FilmArray® System
Guidelines for Laboratory Verification of Performance of the BioFire® COVID-19 Test
Biosafety when Testing Suspected SARS-CoV-2 Samples on the BioFire® FilmArray® System
Selection of Laboratory Performance Verification and Proficiency Testing Materials for use with the BioFire® COVID-19 Test

BioFire® COVID-19 Test SARS-CoV-2 Reactivity

 

BioFire COVID-19 Report Form
BioFire COVID-19 Report Form

 

Not for Diagnostic Use Panels - Product Labeling

BioFire Defense FilmArray Panels

Customer Advisory Notice

FilmArray Panels

BioFire® COVID-19 Test Kits (Kit 423744, Label DFA2-LBL-0058, Lot 311221D) Short-dated Expiration Date on Outer Box Label Customer Acknowledgement of Receipt Form
Increased risk of false positive Pseudomonas aeruginosa results using BioFire® FilmArray® Blood Culture Identification (BCID) Panel (Part No.: RFIT-ASY-0126 and RFIT-ASY-0127) and BioFire® Blood Culture Identification 2 (BCID2) Panel Part No.: RFIT-ASY-0147) with BD BACTEC blood culture vials Customer Acknowledgement of Receipt Form
FilmArray® NGDS Warrior Panel Kits (Part Number: NGDS-ASY-0007) labeled with an Outdated Unique Device Identification (UDI) on the Outer Box Label Customer Acknowledgement of Receipt Form

 

Additional Support Documents

Safety Data Sheets

Product Warranty Documents