Events

Recall of cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). 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-2013-RN-00278-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00278-1
  • 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
    Roche has advised that in rare instanced channel shifted results have been generated with cobas 4800 assays run on v1.X software of the cobas 4800 system. raw data review indicates that in these cases, all signals are shifted by one channel:- channel 1 results report as channel 2- channel 2 results report as channel 3- channel 3 results report as channel 4- channel 4 results report as channel 1. in the reported cases the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid.
  • Action
    Roche is providing end users with work around instructions to mitigate the issue. A software update to detect and mitigate the issue will be implemented in late 2013. This action has been closed-out on 28/01/2016

Device

cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An...
  • Model / Serial
    cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An in vitro diagnostic medical device (IVD).All serial numbers affected
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited