Events

Field Safety Notices about MYLA software when connected to a VITEK 2 system

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

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_20151105_04
  • Event Date Posted
    2015-11-16
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20151105_04
  • 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

MYLA software when connected to a VITEK 2 system
  • Model / Serial
    414518, 415358, 416192, 416546, 417191, 419071, 419072 | All installed systems connected to a VITEK2 system | 414518 V3.2 CLI, 415358 V3.2 CLI, 416192 V3.3 CLI, 416546 V4.0 CLI, 417191 V4.1 CLI, 419071 V4.1 CLI, 419072 V4.1 CLI
  • Product Description
    IVD: Microbial identification mass spectrometry system IVD
  • Manufacturer
    bioMérieux SA

Manufacturer

bioMérieux SA