Events

Field Safety Notices about Acetaminophen Assay (Mulitgent)

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 Sekisui Diagnostics PEI Inc..

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
    241
  • Date
    2015-10-13
  • 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

Acetaminophen Assay (Mulitgent)
  • Model / Serial
    Catalog Number: 2K99-20 Model Number: 2K99-20 Batch Number: 45797UQ04 46121UQ07 46561UQ08 46207UQ09 46953UQ12
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    Sekisui Diagnostics PEI Inc.

Manufacturer

Sekisui Diagnostics PEI Inc.