Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00327-1
Product Name/Description Versant kPCR Molecular System Sample Preparation. An in vitro diagnostic medical device (IVD)

Affected Assays: HIV-1 RNA 1.5, HBV DNA 1.0, HCV RNA 1.0, CT/GC DNA 1.0
Siemens Material Number (SMN): 10282928
All serial numbers affected

ARTG Number: 175890
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/03/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue An issue has been identified regarding an unintended behaviour of the system's result-generation software. It has been observed that an Internal Control displayed a No Baseline error but the assay result for that well was not reported as an Invalid Result. The correct software behaviour is to report the assay result as Invalid Result when the Internal Control for that well displays a No Baseline error. This issue allows for the possibility that an incorrect assay result could be reported for a sample when the result should be invalid and the sample repeated. There is an extremely low risk of false negative results.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is advising users to review each report for the affected Versant IVD assays to identify if there are any No Baseline errors in the IC channel of any wells. If a No Baseline error occurs for the Internal Control of any well, users must not report the assay result for that well and repeat the test. A review of previously generated results is at the discretion of the Laboratory Director.

This action has been closed out on 29/10/2018
Contact Information 1800 008 453 - Siemens Bio-Strategy Technical Support Centre