Urgent Field Safety Notice For Biofire Filmarray Torch By Biofire Diagnostics, LLC

Recall Summary BioFire Diagnostics, LLC has issued an urgent field safety notice for the BIOFIRE FILMARRAY TORCH device. This is a Class I recall, which indicates a serious issue. The affected devices were distributed in Germany and the EU.

Recalling firm
BioFire Diagnostics, LLC
Product
BIOFIRE FILMARRAY TORCH
Reason
Urgent Field Safety Notice for BIOFIRE FILMARRAY TORCH by BioFire Diagnostics, LLC
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-10-22
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/006f3a34-7d3f-4c25-b621-fee3f05c00bf