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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01619-1
Product Name/Description	UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611). An in vitro diagnostic medical device (IVD). Wash Concentrate II Reference Number: 445865 Lot Numbers: Z505212 (expiry 30 April 2017), Z507201 (expiry 30 June 2016), Z511202 (expiry 31 October 2017) ARTG Number: 245295
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/12/2016
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has determined that certain lots of DxC Wash Concentrate II can cause a failure in calibration of Thermo-Fisher Lithium reagent (Ref A19611). The consequence of calibration failure does not allow for patient results to be generated. Lithium calibration failure can potentially lead to a delay of reporting Lithium results. Patient results reported under acceptable calibration and quality control evaluation are not affected by this issue.
Recall Action	Recall
Recall Action Instructions	Beckman Coulter is advising Thermo-Fisher Lithium assay users to discontinue use of affected DxC Wash Concentrate II lots and discard any unused reagent bottles. Replacement product will be provided. Reassessment of past results is not required. This action has been closed-out on 21/03/2018.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre