Field Safety Notices about ALT/ ALTL/ ALTLP/ ALTPM - AST/ ASTL/ ASTLP/ ASTPM - CKMBL/ CKMB/ CK-MB - GLDH/ GLDH3 - NH3/ NH3L, Pro systémy: , cobas c 111 analyzer, cobas c 311 analyzer, cobas c 501 module cobas c 502, module cobas c 701, module cobas c 702 module, cobas c 711 analyzer, COBAS INTEGRA® 400 plus analyzer / system COBAS INTEGRA® 800 analyzer / instrument MODULAR ANALYTICS D-MODULE MODULAR ANALYTICS P-MODULE Roche/HITACHI 902

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 Roche Diagnostics GmbH, Německo.

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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


  • Model / Serial
    Catalog Number: viz FSN Model Number: viz FSN
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer