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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 Device Recall Roche COBAS INTEGRA 400 and 400 plus Analyzersee related information
Date Initiated by FirmNovember 19, 2012
Date PostedJanuary 18, 2013
Recall Status1 Terminated 3 on January 13, 2014
Recall NumberZ-0696-2013
Recall Event ID 63617
510(K)NumberK951595 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductRoche 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 IN 46256-1025
For Additional Information ContactTodd 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		Software design
ActionRoche 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 Commerce845 Units
DistributionNationwide 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
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