Events

Safety Alert for laboratory analyzer Vidas 3

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. || Biomerieux Italia Spa.

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
    I1411-475
  • Event Number
    2014DM-0011236
  • Date
    2014-11-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=192
  • 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
  • Reason
    The manufacturer states that the previous software versions may present clearly identified anomalies related to equipment calibration, negative results for cmvu and cmva tests, as well as false negatives produced by the stability of the urea buffer in cmvu tests, leading to potentially being presented adverse events on the patient due to altered analytical test results.

Device

laboratory analyzer Vidas 3
  • Model / Serial
  • Product Description
    The autonomous VIDAS® 3 immunodiagnostic system is an automated multiparameter analyzer for random access chemo-fluorescence immunoassay (ELFA) tests. It uses urine, serum or plasma samples and fluids for in-vitro diagnostic tests in the areas of deserology, immunology, chemistry, microbiology and coagulation. It is an automated system that reports the values of the tests and communicates the results of the patient's clinics.
  • Manufacturer
    Biomerieux S.A. || Biomerieux Italia Spa

Manufacturer

Biomerieux S.A. || Biomerieux Italia Spa