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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01268-1
Product Name/Description	SYNCHRON Systems Glucose (GLU) cartridge Reagent. An in vitro diagnostic medical device (IVD) All Lot numbers Reference Number: 442640
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/12/2012
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Update to previous Recall for Product Correction (TGA Ref: RC-2010-RN-00834-3). Cartridge Glucose on UniCel DxC and Synchron LX instruments may give falsely high results for moderately haemolysied samples.
Recall Action	Recall for Product Correction
Recall Action Instructions	Beckman Coulter is providing updated Glucose interference tables for users to follow.
Contact Information	1800 060 881 - Beckman Coulter Customer Support