Events

Safety Alert for VIDAS TOXO IgM

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 FRANCIA || Importer: BIOMERIEUX COLOMBIA SAS.

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
    IRD-020216
  • Event Number
    INVIMA 2013RD-0000745-R1
  • Date
    2016-02-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=156
  • 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
    Discrepancy results when using the vidas igm toxo reagent, with inactivated sera by heat (56 ° c for 30 minutes), is not in accordance with the performance characteristics as indicated in the instructions for use, likewise, the investigation confirmed that the obtained index results with activated sera are lower compared to the values obtained with fresh sera, which can result in negative results and lead to inadequate handling of latoxoplasmosis.

Device

VIDAS TOXO IgM
  • Model / Serial
    Lots: 1003987950, 1004061730, 1004084290, || 1004105910, 1004119920, 1004163410, 1004194060, || 1004210630,1004255080, 1004261950, 1004296300, || 1004307590, 1004355660, 1004392080 1004430660, || 1004439320, 1004487160, 1004504650, 1004520730, || 1004533690 and 1004614010
  • Product Description
    DETECTION OF ANTI TOXOPLASM IgM IN HUMAN SERUM
  • Manufacturer
    BIOMERIEUX S.A FRANCIA || Importer: BIOMERIEUX COLOMBIA SAS

Manufacturer

BIOMERIEUX S.A FRANCIA || Importer: BIOMERIEUX COLOMBIA SAS