Events

Safety Alert for Bacteriological analyzer VITEK

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biomerieux, Inc || Biomerieux Bv.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1806-427
  • Event Number
    2008DM-0002355
  • Date
    2018-06-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=40
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data

Device

Bacteriological analyzer VITEK
  • Model / Serial
    VITEK 2, software version 8.01
  • Product Description
    The VITEK bacteriological analyzer is a device whose purpose is to perform clinical microbiology tests for the identification of gram (+), gram (-), anaerobes, fungi and yeasts of clinical importance, as well as the corresponding tests for susceptibility to antibiotics. The readings are carried out by photometric analysis of the color changes in the VITEK identification and susceptibility cards.
  • Manufacturer
    Biomerieux, Inc || Biomerieux Bv

Manufacturer

Biomerieux, Inc || Biomerieux Bv