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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
Roche COBAS INTEGRA 400 and 400 plus Analyzer		see related information
Date Posted January 18, 2013
Recall Number Z-0696-2013
Product Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Code Information Part Numbers: 28065047001 and 03245233001
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis, Indiana 46256-1025
For Additional Information Contact Todd Siesky
317-521-3911
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
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.
Quantity in Commerce 845 Units
Distribution 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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