Events

Field Safety Notices about Bio-Rad RPR 100/Bio-Rad RPR 500/Bio-Rad RPR Cards

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
    843
  • 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

Bio-Rad RPR 100/Bio-Rad RPR 500/Bio-Rad RPR Cards
  • Model / Serial
    Catalog Number: 72505/72506/72508 Batch Number: Bio-Rad RPR 100 (P/N 72505) D040002L 15-Dec-16 D054002L 15-Dec-16 D112042L 16-Feb-17 D113007L 22-Jan-17 D155004L 14-May-17 Bio-Rad RPR 500 (P/N 72506) D040003L 30-Oct-16 D040007L 09-Dec-16 D054001L 15-Dec-16 D113008L 09-Dec-16 D112043L 16-Feb-17 D112044L 16-Feb-17 D155005L 14-May-17 Bio-Rad RPR Cards (P/N 72508) GRN5928 N/A D268005 N/A F089005 N/A
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech