Roche COBAS INTEGRA 400 and 400 plus Analyzer — Class III medical device recall Z-0696-2013
Terminated recall by Roche Diagnostics Operations, Inc., reported 2013-01-30, distributed nationwide. A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied wi
| Recall number | Z-0696-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2012-11-19 |
| Classified | 2013-01-18 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 845 units |
| Reason classes | software |
| Model numbers | 03245233001, 28065047001 |
Product
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0696-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.