Events

Recall of Cobas EGFR MutationTest Kit(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-2015-RN-00091-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00091-1
  • 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
    The cobas egfr mutationtest, lot t08661 is generating false positive results for exon 20 insertion mutations (i.E., false mutation detected results). this mutation is typically only observed in 1-4% of the population depending on the geographic region. the issue is currently under investigation by roche. no other lots or pack sizes of this product are affected by this recall.
  • Action
    Roche Diagnostics Australia is requesting the customers to review their stocks, discontinue use and discard all remaining units of the above lot number. Roche Diagnostics Australia is providing replacement kits to the customers. This action has been closed-out on 15/08/2016.

Device

Cobas EGFR MutationTest Kit(An in vitro diagnostic medical device (IVD))
  • Model / Serial
    Cobas EGFR MutationTest Kit(An in vitro diagnostic medical device (IVD))Catalogue Number: 06471463190Lot Number: T08661ARTG number: 194319
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited