Events

Recall of Biocartis Idylla KRAS Mutation Test IVD

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

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
    20609
  • Event Initiated Date
    2016-09-05
  • 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: Abacus ALS, 12 Mowbray Terrace, East Brisbane, QLD 4169, AUSTRALIA
  • Reason
    A potential increased risk of false positive results of the a59e/g/t mutation by the idylla™ kras mutation test has been identified this could result in an incorrectly reported a59e/g/t mutation. a false positive result on a59e/g/t mutation could lead to sub-optimal patient treatment.
  • Action
    Instructions for use to be updated

Device

Biocartis Idylla KRAS Mutation Test IVD
  • Model / Serial
    Model: , Affected: Lot 2663
  • Manufacturer
    Biocartis NV

Manufacturer

Biocartis NV