| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00649-1 |
| Product Name/Description |
Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical chemistry analyser. An in vitro diagnostic medical device (IVD)
Siemens Material Numbers: 10488224 and 10444802
ARTG Number: 174699 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare has confirmed that, under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot well, the first sample will always be QC or calibrator from a Vista vial. Patient sample will never be dispensed into an aliquot well that contains another patient sample. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In the event of an instrument reset, end users are requested to check if there are any QC or calibration tests pending. If there are QC or calibrations pending a software restart is necessary before resuming patient processing. If there is no QC or calibration pending reset or troubleshoot the instrument as per the Operators Guide. A software update will be provided as a permanent fix. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |