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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01043-1
Product Name/Description ADVIA Centaur XPT. An in vitro diagnostic medical device (IVD)

Catalogue Number: 10711433

ARTG Number: 175890

An in vitro diagnostic medical device (IVD)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/10/2015
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens Healthcare Diagnostics has identified multiple issues with the ADVIA Centaur XPT system software V1.0.1 (Bundle 1.0.912 SMN 10819704) and V1.0.2 (Bundle 1.0.1086 SMN 11219806)
Recall Action Recall for Product Correction
Recall Action Instructions Users are provided a detailed workaround in the customer letter whilst a software upgrade is being scheduled.
This action has been closed-out on 21/03/2018.
Contact Information 1800 310 300 - Siemens Technical Support Centre