Events

Field Safety Notices about Multiplate Analyzer

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland that was produced by Roche Diagnostics GmbH.

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_20161223_01
  • Event Date Posted
    2017-01-03
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20161223_01
  • 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

Multiplate Analyzer
  • Model / Serial
    6675069001 | All systems with SW 2.04 SN >101513 and all systems with updated SW version to SW 2.04
  • Product Description
    IVD: Laboratory coagulation analyser IVD, semi-automated
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH