Events

Recall of Device Recall Roche COBAS INTEGRA 400 and 400 plus Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63617
  • Event Risk Class
    Class 3
  • Event Number
    Z-0696-2013
  • Event Initiated Date
    2012-11-19
  • Event Date Posted
    2013-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114368
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    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.

Device

Device Recall Roche COBAS INTEGRA 400 and 400 plus Analyzer
  • Model / Serial
    Part Numbers: 28065047001 and 03245233001
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Roche COBAS INTEGRA 400 and 400 plus Analyzer, || an in vitro diagnostic analyzer.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA