Safety Alert for cholesterol, triglyceride, uric acid

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 || Importer: ROCHEM BIOCARE COLOMBIA 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
    IRD-050416
  • Event Number
    INVIMA 2015RD-0003186
  • Date
    2016-04-20
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 parent company notifies the possibility of having interferences when administering the medicament metamizol (dipyrone), which may generate falsely low results. the problem was discovered internally on february 23, 2016 by beckman coulter.

Device

  • Model / Serial
    CHOLESTEROL: references OSR6116, OSR6216, OSR6516 || OSR6616. All lots || TRIGLYCERIDE: references OSR60118, OSR61118, || OSR66118. All lots || URIC ACID: references OSR6098, OSR6198, OSR6298. All || The lots
  • Product Description
    DETERMINATION OF THE DIFFERENT ANALYTS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION.
  • Manufacturer

Manufacturer