| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00574-1 |
| Product Name/Description |
syngo Lab Data Manager. Middle-ware for use with in vitro diagnostic medical devices (IVD).
Software Versions: VA11B, VA12A, VA12B
Siemens Material Numbers: 10800057, 10803189, 1084573 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
In the Assay Details screen, certain configuration parameters selected during configuration of reference ranges for assays may cause the reference ranges to not hold results as expected. This may cause the release of results to the Laboratory Information System (LIS) that should have been held for manual review. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is notifying hospitals and laboratories of specific limitations with the use of sample reports in the syngo Result Manager that have not been previously communicated in the Operator's Guide. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |