Events

Recall of Roche cobas EGFR Mutation Test z480

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Roche Diagnostics GmbH.

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
    20014
  • Event Initiated Date
    2016-04-12
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    When testing plasma specimens, several mutations inconsistently generated "no mutation detected" (i.E false negative) results with the cobas egfr mutation test, v2 when utilising the cobas cfdna sample preparation kit., , potential inhibition of plasma samples with the cobas® egfr mutation test, v2 ce-ivd when used in conjunction with the cobas® cfdna sample preparation kit.
  • Action
    Manufacturer to issue advice regarding use

Device

Roche cobas EGFR Mutation Test z480
  • Model / Serial
    Model: 0748563190 and 07247737190, Affected: , Software version: v2 CE-IVD
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH