Safety Alert for VIDAS / MINIVIDAS BIOMERIEUX Analyzer

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

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
    I1802-109
  • Event Number
    2008DM-0002498
  • Date
    2018-02-23
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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

  • Model / Serial
  • Product Description
    The equipment is a multiparametric automated analyzer for random access immunoassays by chemo fluorescence (ELFA). It uses urine, serum or plasma samples and fluids for in-vitro diagnostic tests in the areas of serology, immunology, chemistry, microbiology and coagulation. . It is in automated system that reports the values of the tests and communicates the clinical results of the patient.
  • Manufacturer

Manufacturer