Events

Recall Or Safety Alert for Lifecycle for prenatal screening ", model 5014-0020, catalog number 5014-0020 and software versions v4.0, v4.0 Rev. 2 and v4.0 Rev. 3, manufactured by Wallac Oy, Finland.

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Wallac Oy, Finlandia.

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
    Recall / Safety Alert
  • Date
    2015-07-08
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Possibility of error in the calculation of risk for twins with the "Lifecycle for prenatal screening" system, model 5014-0020, manufactured by Wallac Oy, Finland, if the risk calculation protocol v4.0 is used, under certain circumstances.

Device

Lifecycle for prenatal screening ", model 5014-0020, catalog number 5014-0020 and software versio...

Manufacturer

Wallac Oy, Finlandia