| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00520-1 |
| Product Name/Description |
Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in vitro diagnostic medical device (IVD))
Siemens Material Numbers: 10488224, 10444802
ARTG Number: 174699 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has confirmed that there is potential for the vial volume of "in use" Vista calibrators, controls or sample diluent to incorrectly revert to full volume when removed and reloaded.
If Vista vials revert to full volume, insufficient volume may result in the following:
- Calibrator Vial – failed calibration
- Control Vial – low out of range QC
- Sample Diluent Vial – auto-diluted results will flag with an Above Assay Range error or a falsely elevated diluted result above the assay range will occur for the following methods: CTNI, E2, or TSH. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing temporary work around instructions and is in the process of implementing Vista software version 3.6. Siemens is planning to send additional communication to customers when the software is available. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |