Biofire? Filmarray? Blood Culture Identification (bcid) Panel (2021-01-27)

Recall Summary BioFire FilmArray Blood Culture Identification (BCID) Panel cartridges have been recalled across Canada due to a defect in the medical device. The cartridges may produce false negative results, meaning they could fail to detect certain bacterial or fungal infections in blood samples when those infections are actually present. This recall affects healthcare facilities and laboratories that use this diagnostic testing system.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-02-12

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/174ca29e-28be-410e-b7b2-938883850c6a