Z-0696-2013 Class III Terminated
FDA device recall Z-0696-2013 was initiated by Roche Diagnostics Operations, Inc. on Nov 19, 2012 and is designated Class III. 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… The recall status is terminated (terminated Jan 13, 2014). Affected quantity: 845 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 30, 2013
- Initiation Date
- Nov 19, 2012
- Termination Date
- Jan 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 845 Units
Product Description
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
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.
Code Information
Part Numbers: 28065047001 and 03245233001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0696-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026