Events

Safety Alert for TPHA test

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BIO RAD || Imported by: QUIK QUALITY IS THE KEY S.A.S..

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-021016
  • Event Number
    INVIMA 2012RD-0002383
  • Date
    2016-10-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=118
  • 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 health agency notifies, that trinity biotech informs that during the quality control of the european edqm.

Device

TPHA test
  • Model / Serial
    Reference 72507 No. of lots D336012, D352016, D355019, || D217008L, D216007L, D303009, D331028, F190002.
  • Product Description
    KITS FOR THE QUALITATIVE AND SEMICUANTITATIVE DETECTION OF TREPONEMAPALLIDUM ANTIBODIES IN SERUM OR HUMAN PLASMA THROUGH PASSIVE HAEMAGGLUTINATION.
  • Manufacturer
    BIO RAD || Imported by: QUIK QUALITY IS THE KEY S.A.S.

Manufacturer

BIO RAD || Imported by: QUIK QUALITY IS THE KEY S.A.S.