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OFFICIAL-SOURCE RECALL · AUSTRALIA

BIOFIRE FILMARRAY TORCH System Base. An in vitro diagnostic medical Recall: Classification Class II Reason

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CountryAustraliaPublishedSeptember 16, 2024Last updatedSeptember 16, 2024Official source last checkedAugust 26, 2026 at 7:44 PM UTC

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Product
BIOFIRE FILMARRAY TORCH System Base. An in vitro diagnostic medical device (IVD).
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Why this product was recalled

Classification Class II Reason for the Action Power cycling can lead to arcing inside of the power switch and may result in carbon build-up and/or deformation of the power switch case. Carbon build-up and/or deformation may result in an open circuit causing the power switch to fail. bioMérieux has developed a fused extension cable to be installed on each BIOFIRE FILMARRAY TORCH System Base. The fuse between the power source and power switch would open the circuit and prevent risk of fire, burns, smoke, and electrical shock to the operator, at the power entry module. This market action follows a previous Product Correction RC-2023-RN-00998-1. Instructions for Customers/Users Customers are to: - Install the fused extension cable upon receipt from bioMérieux. Action Commencement Date 21/08/2026 Responsible Entity Biomerieux Australia Pty Ltd

Hazard

Classification Class II Reason for the Action Power cycling can lead to arcing inside of the power switch and may result in carbon build-up and/or deformation of the power switch case. Carbon build-up and/or deformation may result in an open circuit causing the power switch to fail. bioMérieux has developed a fused extension cable to be installed on each BIOFIRE FILMARRAY TORCH System Base. The fuse between the power source and power switch would open the circuit and prevent risk of fire, burns, smoke, and electrical shock to the operator, at the power entry module. This market action follows a previous Product Correction RC-2023-RN-00998-1. Instructions for Customers/Users Customers are to: - Install the fused extension cable upon receipt from bioMérieux. Action Commencement Date 21/08/2026 Responsible Entity Biomerieux Australia Pty Ltd

Official recall notice

BIOFIRE FILMARRAY TORCH System Base. An in vitro diagnostic medical device (IVD).

Agency: Therapeutic Goods Administration

Official publication date: September 16, 2024

Read the official AU_TGA_DRAC recall notice →

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