| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01192-1 |
| Product Name/Description |
Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab System
Dimension Vista 500 Intelligent Lab System
Catalogue Number: 10488224
Dimension Vista 1500 Intelligent Lab System
Catalogue Number: 10444802
ARTG Number: 174699 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has received customer complaints of discrepant flagged and un-flagged patient and QC results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare Diagnostics has confirmed that reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing additional instructions to assist laboratories in determining when the replace the reagent probe. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |