| 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 |
|
| 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 |