Recall Z-0353-2024— BioFire Diagnostics, LLC

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2023-10-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.. Reason: 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..

Recalling firm

BioFire Diagnostics, LLC

Classification

Class II

Status

Ongoing

Initiated

2023-10-17

Firm location

Salt Lake City, UT, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.