Events

Safety Alert for Access Free T3

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BECKMAN COULTER INC. || Imported by: ROCHEM BIOCARE COLOMBIA S.A./ || ANÁLISIS TÉCNICOS 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
    IRD-030616
  • Event Number
    INVIMA 2006RD-0000208
  • Date
    2016-06-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • 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
    Positive displacement in the patient's results. the preliminary results indicate that this increase in the results may be related to a change in the reagent formulation in june 2015, which was introduced to improve the stability of the product once it was opened. the results of patient samples shifted by 10-14% over the entire reference interval, in contrast to the results generated with batches of reagents manufactured prior to the design change in june 2015. notwithstanding the foregoing, the performance characteristics of the additional test did not they seem affected.

Device

Access Free T3

Manufacturer

BECKMAN COULTER INC. || Imported by: ROCHEM BIOCARE COLOMBIA S.A./ || ANÁLISIS TÉCNICOS LTDA