| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01095-1 |
| Product Name/Description |
Cobas IT 3000 version 2.03.04 to 2.04.00, Cobas 8000 Data Manager version 1.02.02 to 1.02.05, Cobas INTEGRA 400 and Cobas INTEGRA 400 Plus. In vitro diagnostic medical devices (IVD).
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential security vulnerability with the Oracle TNS-Listener component due to an insecure default configuration. The TNS-Listener is part
of the software Roche supplied with the above mentioned products. The vulnerability may allow attackers to modify the content of a database from a
remote system if the Roche Products are located on a network with insufficient security to prevent unauthenticated access. Oracle has issued a Security Alert entitled "CVE-2012-1675 Oracle TNS Listener Poisoning". |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
|
| Contact Information |
1800 645 619 - National Support Centre |