Events

Field Safety Notices about MYLA®

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 bioMérieux SA.

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
    335
  • Date
    2015-12-08
  • 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

MYLA®
  • Model / Serial
    Catalog Number: 414518 415358 416192 416546 417191 419071 419072 Model Number: All installed systems connected to a VITEK2 system Serial Number: 414518 2013 415358 2013 - 2015 416192 2013 - 2015 416546 2014 - 2015 417191 2015 - on going 419071 2015 - on going 419072 2015 - on going
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    bioMérieux SA

Manufacturer

bioMérieux SA