Events

Field Safety Notices about Idylla™ KRAS Mutation Test

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Biocartis.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    190
  • Date
    2015-09-15
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

Idylla™ KRAS Mutation Test
  • Model / Serial
    Catalog Number: A0020 Batch Number: KRAS Mutation Test CE-IVD lot 2207 Manufacturing date: 2015-06-24 Expiry date: 2015-10-24 KRAS Mutation Test CE-IVD lot 2208 Manufacturing date: 2015-06-26 Expiry date: 2015-10-26
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    Biocartis

Manufacturer

Biocartis