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U.S. Department of Health and Human Services

Class 3 Device Recall Roche COBAS INTEGRA 400 and 400 plus Analyzer

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 Class 3 Recall
Roche COBAS INTEGRA 400 and 400 plus Analyzer
see related information
Date Posted January 18, 2013
Recall Status1 Terminated on January 13, 2014
Recall Number Z-0696-2013
Recall Event ID 63617
Premarket Notification
510(K) Number
K951595 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Software Design
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ROCHE DIAGNOSTIC SYSTEMS, INC.
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