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Recall Observatory FDA recall evidence

Device product

Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.

Z-0696-2013

November 19, 2012

Class III

Product summary

Firm
Roche Diagnostics Operations, Inc.
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

    reason.device_software_design · v1.0.0

    software security issue