Events

Recall of cobas 8000 core unit with software versions 5.01 and later. 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-2017-RN-01115-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01115-1
  • 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
    Due to a software limitation, in very rare cases, roche has identified that the system configuration of the control unit software may be reset to its default settings.For instruments which are connected to laboratory automation systems (clas) and/or are running in barcode mode, if the issue has occurred and at the start of the next operation:-barcodes are no longer read-rack loading from clas is no longer possible-additional settings may revert to default settings during operationroche has received 6 complaints globally to date; none from australian customers. there is a risk of incorrect results, especially when “alarm settings” and “analyzer settings” unknowingly revert to “default” settings.
  • Action
    1. If the software issue is detected, stop the instrument using the “Stop” button and contact the Roche Diagnostics Australia call centre on 1800 645 619, quoting the Roche reference number "CPS-2017-017". 2. After the system settings have been restored by Roche Diagnostics Australia personnel re-run any samples which were measured in the period between the issue occurring and the instrument being stopped. 3. Retain this letter until the software upgrade has been installed. 4. Acknowledge receipt of this communication via the link/email address in the supplied customer letter, even if no system which is subject to this recall is on-site, as this information is required to reconcile this process.

Device

cobas 8000 core unit with software versions 5.01 and later. An in vitro diagnostic medical device...
  • Model / Serial
    cobas 8000 core unit with software versions 5.01 and later. An in vitro diagnostic medical device (IVD)Material Number: 05641446001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited