| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00268-1 |
| Product Name/Description |
CentraLink Database Management System, version 14.0.4 (An in vitro diagnostic medical device (IVD))
Catalogue Numbers: 10810208, 10810209, 10810210, 10810211, 10811596, 10811597, 10811598, 10811599, 10811600 & 10811601 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
A system database anomaly has been identified that may cause instrument results in certain situations to not be accepted by the CentraLink system. At the same time, the operator may receive no indication of this rejection. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are being provided with work around instructions to ensure all patient results are reported. Siemens will be providing a future correspondence once a correction has been designed. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |