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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01135-1
Product Name/Description ADVIA Centaur and ADVIA Centaur XP

Siemens Material Numbers: 10321568, 10329339, 10364455

ARTG Number: 175890
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 18/11/2015
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue A potential vacuum leak may occur around the Glass Rod Sensor in the Waste Reservoir, caused by the gasket on the housing of the Glass Rod Sensor sliding out of position. If the error occurs, the analyser will alarm and no results will be generated.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is advising users to inspect the gasket under the Glass Rod Sensor if an error code due to low vacuum is displayed, and contact Siemens Technical Support for a replacement gasket if required. Siemens will be inspecting the Glass Rod Sensor on all analysers during the next service visit to replace if necessary.
Siemens recommends discussing this notification with the laboratory director.

This action has been closed out on 14/06/2019
Contact Information 1800 310 300 - Siemens Technical Support Centre