Biofire® Filmarray® 2.0 Instruments And Biofire® Filmarray® Torch Module Box

Recall Summary BioFire FilmArray 2.0 Instruments and BioFire FilmArray Torch Module Boxes are being recalled across Canada due to performance issues. These are diagnostic testing devices used in medical laboratories. The recall is classified as Class I, meaning there is a serious potential health risk associated with the performance problem.

Product
BioFire® FilmArray® 2.0 Instruments and BioFire® FilmArray® Torch Module Box
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2024-08-29
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/5cd4e207-1814-44d8-aef6-8f975c66ff5d