Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
FDA Recall Z-0696-2013 · Posted 2013-01-18
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Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2012-11-19
Date Terminated2014-01-13
Product Quantity845 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
Firm Action
Roche sent an Urgent Medical Device Correction letter on November 19, 2012, to all affected customers via UPS Ground (receipt required). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached form and return by fax and file this Medical Device Correction for future reference. For technical support customers were instructed to contact Diagnostics Technical Support at 1-900-428-2336.
For questions regarding this recall call 317-521-3911.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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