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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00143-1
Product Name/Description Access 2 Immunoassay Systems
Catalogue numbers: 81600N, 386220, A69186, A12900, A56158, A65531

UniCel DxC 600i SYNCHRON Access Clinical System
Catalogue numbers: A25640, A25638, A25637, A25635, A25656, A25634

An in vitro diagnostic device (IVD)

ARTG Number: 177999
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 13/03/2015
Responsible Entity Beckman Coulter Australia Pty Ltd
Reason/Issue Beckman Coulter is advising the users that it is releasing Access 2 system software version 3.4.2 and Access 2i (UniCel DxC 600i System) software version 6.2.2 to address the reagent pack volume issues notification that was distributed August 13, 2010. The notification discussed the risks associated with assay reagent packs that were loaded incorrectly, or reagent packs that were inappropriately transferred between two systems (pack sharing). With these software versions, the new Reagent Pack Monitoring feature enables the Access 2 system pressure monitoring hardware to detect packs with insufficient volume, as well as packs that are improperly loaded or missing.
Recall Action Recall for Product Correction
Recall Action Instructions Beckman Coulter is providing customer-installable 3.4.2 or 6.2.2 software disc along with an information packet that describes the new reagent pack monitoring feature to all customers in Australia. This action has been closed-out on 20/06/2016.
Contact Information 1800 060 881 - Beckman Coulter Customer Support Centre