Enforcement Report - Week of January 30, 2013
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Product Detail
| Product Description | Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. |
|---|---|
| Recall Number | Z-0696-2013 |
| Classification | Class III |
| Code Info | Part Numbers:28065047001 and 03245233001 |
| Product Distributed Qty | 845 Units |
| 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 over the network to the Roche product and read and write database queries without authentication and therefore modify the content of a database. |
Event Detail
| Event Id | 63617 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| City | Indianapolis |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-11-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
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