Filmarray Gi Panel (2019-03-07)

FilmArray GI Panel Recall Summary The FilmArray GI Panel, a medical diagnostic device used to identify gastrointestinal pathogens, was recalled across Canada due to safety or performance concerns classified as Class I (the most serious type). The recall affects healthcare facilities and laboratories that use this device for patient testing.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-04-05
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4e943fff-1019-42aa-8669-3ac95a930808