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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00481-1
Product Name/Description	ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD) Model Number: 186015020IVD Lot Numbers: G13UPO544M, J13UPO553M, G13UPO542M ARTG Number: 201428
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/04/2017
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	The manufacturer, Waters Corporation has identified an issue with the ACQUITY UPLC Sample Organisers, whereby there is a potential for an internal fuse shield to combust, resulting in a burning odour and instrument failure. An investigation concluded that the potential combustion of the fuse shield would be contained within the instrument with no risk of damage to the samples or the surrounding areas.
Recall Action	Recall for Product Correction
Recall Action Instructions	Emergo will send a field engineer to attend the user's facility to modify the affected device (by removing the internal fuse). In the interim, users are advised that if they note a burning odour in or around the instrument, to immediately power down the unit, discontinue use, and call their local representative to report the event. This action has been closed-out 16/03/2018.
Contact Information	02 9006 1662 - Emergo Australia