Safety Alert for placental growth factor Delfia Xpress PIGF Kit

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by PerkinElmer/ ROPSOHN THERAPEUTICS 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
  • 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
    Stability problem of the calibrators that are included in the pigf kits, which causes loss in the signal level measured up to 20%.


  • Model / Serial
    LOT: 637341
  • Product Description
    Quantitative determination of the placental growth factor (PIGF) in the maternal serum used the clinical random access screening platform 6000 DELFIA XPRESS
  • Manufacturer