Events

Field Safety Notices about MicroTrak® RPR Syphilis

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 Trinity Biotech.

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
    845
  • Date
    2016-11-14
  • 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

MicroTrak® RPR Syphilis
  • Model / Serial
    Catalog Number: 8H60070, 8H60070A, 8H60071, 8H60071A, 8H60071B, 8H52215, 8H52216, 23805/23040 Batch Number: MicroTrak® RPR Syphilis 100 8H60070, F008005 14-May-17, F173079 22-Oct-17 MicroTrak® RPR Syphilis 100 (+ pipstirs) 8H60070A , D007037 30-Oct-16, D047045 30-Oct-16, F179011 14-May-17, D217013 22-Oct-17 MicroTrak® RPR Syphilis 500 8H60071, F008006 27-Feb-17 MicroTrak® RPR Syphilis 500 (+ pipstirs) 8H60071A, D301035 27-Feb-17, F025047 27-Feb-17, MicroTrak® RPR Syphilis 500 (+ pipstirs) 8H60071B, D077002 22-Jan-17, D167001 22-Jan-17, D301037 10-Jun-17, F074003 08-Mar-18, F179014 14-Mar-18, F203003 14-Mar-18, MicroTrak® RPR 1 Antigen 100 ml 8H52215, D057023 18-Feb-17, D167002 21-May-17, F179007 15-Oct-17, F179006 14-Mar-18, MicroTrak® RPR 1 Antigen 5 ml 8H52216, D057018 18-Feb-17, D167003 21-May-17, D189009 21-May-17, F090001 14-Mar-18, F175041 14-Mar-18, RPR Carbon Cards 23805/23040, GRN161148 N/A, GRN168315 N/A, GRN170867 N/A
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech