Device product
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Z-0696-2013
Product summary
- Event
- Event 63617
- Status
- Terminated
- Classification
- Class III
- Quantity
- 845 Units
- Official record key
device-enforcement:Z-0696-2013
Official wording
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
Code information: Part Numbers: 28065047001 and 03245233001
Distribution pattern: Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.
Derived failure modes
-
Device software or design
software security issue