Events

Recall of Cobas 4800 BRAF V600 Mutation Test (acquired genetic alteration IVD). 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-00790-3
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-08-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00790-3
  • 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
    The test kit was assembled containing two components, the wt control and the mu control, that were released for non-commercial internal use only.
  • Action
    Discontinue the use of affected product and dispose them appropriately. There is no requirement to re-test samples tested with the affected product. Roche will be supplying replacement stock when available.

Device

Cobas 4800 BRAF V600 Mutation Test (acquired genetic alteration IVD). An in vitro diagnostic medi...
  • Model / Serial
    Cobas 4800 BRAF V600 Mutation Test (acquired genetic alteration IVD). An in vitro diagnostic medical device (IVD)Material Number: 05985595190Lot Number: R03607ARTG Number: 192394
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited