Safety Alert for SD BIOLINE PSA

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ESTÁNDARD DIAGNOSTICS, INC.

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
  • Event Number
  • Date
  • Event Country
  • Event Source
  • 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
    Difference between the cut reported in the insert (3ng / ml) and the real one of 5ng / ml, which can generate false negatives.


  • Model / Serial
    Reference. 22FK10. Lots 22AD14001, 22AD14002
  • Product Description
    One step in vitro immunochromatographic assay designed for the qualitative determination of PSA in human oplasm serum.
  • Manufacturer


  • Source