Events

Field Safety Notices about cobas 8000,

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland that was produced by Hitachi High-Technologies.

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
    Vk_20170227_10
  • Event Date Posted
    2017-03-06
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20170227_10
  • Notes / Alerts
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 recall data from the U.S. and Switzerland.
  • Extra notes in the data

Device

cobas 8000,
  • Model / Serial
    e 602 module (05990378001), e 801 module (07682913001)
  • Product Description
    IVD: Chemiluminescent immunoassay analyser IVD, automated
  • Manufacturer
    Hitachi High-Technologies

Manufacturer

Hitachi High-Technologies