Events

Safety Alert for Access Thyroglobulin calibrators

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Beckman Coulter/ Rochem Biocare.

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-040815
  • Event Number
    2008RD- 0001135
  • Date
    2015-08-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=173
  • 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
    Beckman coulter has determined that lots of the tiroglobulin access package shown above can show an inaccuracy of more than 10% in concentrations below 10 ng / ml.

Device

Access Thyroglobulin calibrators
  • Model / Serial
    Reference 33860, Lot: 430969-431990-434727-522896-523251
  • Product Description
    Quantitative determination of serum and plasma thyroglobulin levels in humans
  • Manufacturer
    Beckman Coulter/ Rochem Biocare

Manufacturer

Beckman Coulter/ Rochem Biocare
  • Source
    NIDFSINVIMA