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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00018-1
Product Name/Description	Synchron Enzyme Validator. An in vitro diagnostic medical device (IVD). Reference Number: 441350 Lot Number: M612600 Expiry: 31/08/2018 ARTG Number: 213974
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/01/2018
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has identified that a Supplemental Product Information notification is missing from Enzyme Validator kit Lot M612600 due to the introduction of a new lot of traceable reference material in the manufacturing process. As a result, calibration with this Lot may demonstrate differences in AST- or GGT patient and control values compared to calibration with previous lots. Other enzyme assays are not affected.
Recall Action	Recall for Product Correction
Recall Action Instructions	Beckman Coulter is advising affected customers to refer to the Supplemental Product Information provided with the Customer Letter for adjusting set points of AST- and GGT assays. This action has been closed out on 25/02/2019
Contact Information	1800 060 881 - Customer Support Centre