FDAOctober 17, 2023device

FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire Fi...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.

What to do

FDA enforcement status: Ongoing

Brands named

biofire diagnosticsbiofire

UPCs

00815381020253

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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