Events

Recall of cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software). An in vitro diagnostic medical device (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-01299-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01299-1
  • 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 issue regarding the date of birth demographic in it 1000 when a change in timezone is made on the it 1000 server. if the user enters a patient date of birth manually in "results & results>single patient edit", the cobas it 1000 application may save an earlier date instead, the most common example being that the date of birth is listed as the day prior. for example; a patient date of birth is entered as 01-nov-1931 and is saved as 31-oct-1931.
  • Action
    Roche is providing work around instructions for users to implement.

Device

cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software)...
  • Model / Serial
    cobas IT 1000, version 2.00.00.02 to current, ESX 4.1 platform virtual server (Analyser software). An in vitro diagnostic medical device (IVD)ARTG Number: 174914
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited