Events

Field Safety Notices about HIV/HVC/HBV tests

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 BIOSYNEX 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
    724
  • Date
    2016-09-01
  • 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

HIV/HVC/HBV tests
  • Model / Serial
    Catalog Number: 857318, 1150004, 5059, 0556, 1150002, 5058, 0557, 1150003, 5060, 0558 Model Number: Exacto Pro test HIV, Biosynex HIVTOP, HIVTOP, Immunoquick HIV, Biosynex HCV, HCVTOP, Immunoquick HCV Biosynex HBV, HBVTOP, Immunoquick HBsAg Batch Number: Všechna čísla šarží
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    BIOSYNEX SA

Manufacturer

BIOSYNEX SA
  • Manufacturer Parent Company (2017)
    Biosynex
  • Source
    MHSIDCCCDMIS