| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00521-1 |
| Product Name/Description |
syngo Lab Data Manager Version VA11B and VA12A. An in vitro diagnostic medical device (IVD)
Software version: VA11B
Siemens Material Number: 10800057
Software version VA12A
Siemens Material Number: 10803188 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens has provided their customers with work around instructions. A software fix is under development and will be provided in a future software release. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |