Reported Jan 30, 2013 · Terminated
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Roche Diagnostics Operations, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Road · Indianapolis, IN · 46256-1025
Is this the product you have?
- Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
- Lot codes and dates
- Part Numbers28065047001 and 03245233001
- Amount recalled
- 845 Units
Where it was sold
Why it was recalled
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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