Events

Field Safety Notices about cobas 6800 system / cobas 8800 system - 05524245001/05412722001

According to Ministero della Salute (Health Ministry), this field safety notices involved a device in Italy that was produced by ROCHE DIAGNOSTICS.

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
    7403
  • Date
    2017-05-26
  • Event Country
    Italy
  • Event Source
    MSHM
  • Event Source URL
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=7403
  • Notes / Alerts
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 Italy.
  • Extra notes in the data
  • Action
    Safety instructions

Device

cobas 6800 system / cobas 8800 system - 05524245001/05412722001

Manufacturer

ROCHE DIAGNOSTICS