Events

Safety Alert for TREPANOSTIKA TP RECOMBINANT

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BIOMERIEUX BV || Importer: BIOMERIEUX COLOMBIA LTDA.

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
    RRD-050416
  • Event Number
    INVIMA 2008RD-0000953
  • Date
    2016-04-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=146
  • 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 negative control of this test is outside the upper limit, so invalid series are generated and the results of the clinical tests can not be calculated. according to the report, there is no risk of false results or misinterpretation of them, however, this failure can generate reprocessing.

Device

TREPANOSTIKA TP RECOMBINANT
  • Model / Serial
    References: 285034 and 285035, lots: D36EA, D36EC and D36GA
  • Product Description
    IT IS AN IMMUNOANALYSIS FOR THE QUALITATIVE DETERMINATION OF SPECIFIC ANTIBODIES FOR PALLIDUM ELTREPONEMA IN SERUM OR HUMAN PLASMA.
  • Manufacturer
    BIOMERIEUX BV || Importer: BIOMERIEUX COLOMBIA LTDA

Manufacturer

BIOMERIEUX BV || Importer: BIOMERIEUX COLOMBIA LTDA