Events

Recall of Cobas IT 3000 version 2.03.04 to 2.04.00, Cobas 8000 Data Manager version 1.02.02 to 1.02.05, Cobas INTEGRA 400 and Cobas INTEGRA 400 Plus. In vitro diagnostic medical devices (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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
    RC-2012-RN-01095-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01095-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    There is a potential security vulnerability with the oracle tns-listener component due to an insecure default configuration. the tns-listener is part of the software roche supplied with the above mentioned products. the vulnerability may allow attackers to modify the content of a database from aremote system if the roche products are located on a network with insufficient security to prevent unauthenticated access. oracle has issued a security alert entitled "cve-2012-1675 oracle tns listener poisoning".

Device

Cobas IT 3000 version 2.03.04 to 2.04.00, Cobas 8000 Data Manager version 1.02.02 to 1.02.05, Cob...
  • Model / Serial
    Cobas IT 3000 version 2.03.04 to 2.04.00, Cobas 8000 Data Manager version 1.02.02 to 1.02.05, Cobas INTEGRA 400 and Cobas INTEGRA 400 Plus. In vitro diagnostic medical devices (IVD).
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited