Events

Recall of Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). 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-01113-1
  • 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-01113-1
  • 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
    A software bug has been detected on the cobas 8000, cobas c 701/702 modules, which under certain conditions can lead to a mismatch between reagent probe positioning during pipetting and the aspirate sample volumes, leading to possible incorrect results. until the new software version is available, roche have updated the application e-barcodes for the affected assays, which reduce the number of available tests.
  • Action
    Roche will be providing work around instructions to mitigate the risk and will be providing a software update to permanently correct the issue.

Device

Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry ana...
  • Model / Serial
    Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). An in vitro diagnostic medical device (IVD)Multiple affected assays
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited