| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00893-1 |
| Product Name/Description |
EasyLink Data Management System, all versions (used for connecting multiple IVD instruments to Laboratory Information System (LMS))
Siemens Material Number: 10444799, 10444800 & 10487219 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/08/2013 |
| 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 LIS. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are requested to determine if they are affected and to implement work around to ensure the issue does not occur. If affected, look back at previous results should be carried out at the discretion of the laboratory director. Software update is available to permanently fix the issue. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |