Events

Field Safety Notices about VITEK 2 Compact 15/30 Systems

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

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_20180226_03
  • Event Date Posted
    2018-03-01
  • Event Status
    2018-03-07
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20180226_03
  • 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
  • Reason
    Added new language.

Device

VITEK 2 Compact 15/30 Systems
  • Model / Serial
    27415, 27415R, 27530, 27530R, 27630, 27630R | 8.01 version
  • Product Description
    IVD: Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
  • Manufacturer
    bioMerieux Inc

Manufacturer

bioMerieux Inc