FDA Device recall Z-0696-2013
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer
- FDA Device
- Class III
- terminated
- Published 2013-01-30
On 2013-01-30 the FDA classified a Class III recall of Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer by Roche Diagnostics Operations, citing A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Lis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0696-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-11-19 |
| Published | 2013-01-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Reason
A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access
Identifiers
| code_info | Part Numbers: 28065047001 and 03245233001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0696-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.