Adverse Event Reporting for BioFire COVID-19 Test

 

Use this form to report any adverse events associated with the BioFire® COVID-19 Test.

BioFire will contact you for further information once this report has been submitted. If you have any questions or concerns regarding this report or the BioFire COVID-19 test, please contact us online or at 1-801-262-3592.

>> Click here to view our BioFire COVID-19 Test EUA documents.

 

  • Upload Data Files

    Please export the relevant anonymized data files from the FilmArray instrument and upload these files here. The FilmArray instrument manual contains instructions for exporting files.
  • Explanation of Adverse Events

    Please describe the adverse event below. Please include details of:
    • Suspected false positive or negative results
    • Suspected safety or performance issues
    • Sample type
    • Number of tests involved
    • Patient outcomes if known