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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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- 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
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