| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00430-1 |
| Product Name/Description |
Dimension Vista 500 and 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD)
Software version: 3.6.1, 3.6.1_MU3p and 3.6.1SP1
ARTG Number: 174699 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Issue 1:
Samples may stop processing without notification on the Dimension Vista 500 or Dimension Vista 1500. This issue is due to a failure to exchange aliquot plates, causing the lane to become unavailable.
Issue 2:
Complaints were received on the Dimension Vista 1500 for a series of unexpected results, some of which were not flagged with errors or results that were flagged with errors. It has been determined that under a rare set of conditions, a timing issue may cause a Reagent Server to temporarily lose synchronisation during the automatic removal of reagent cartridges from Reagent Server 2 to Waste A Container. In the extremely unlikely circumstance that this issue occurs, a flag will be generated for the majority of assays. However, there is the potential to produce unflagged erroneous but believable results for some assays. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are provided with temporary workarounds in the customer letter. Siemens will be providing corrections for the issues in a future Vista software version. Review of previously generated results due to this issue is at the discretion of laboratory. This action has been closed-out on 26/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |