Events

Recall Or Safety Alert for Assay "Acetaminophen" reference 2K99-20, manufactured by Sekisui Diagnostics, LLC., USA.

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 Sekisui Diagnostics, LLC..

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
    2015-07-10
  • 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 a negative bias in the determination of paracetamol, when using certain batches of the "Acetaminophen" test, reference 2K99-20, manufactured by Sekisui Diagnostics, LLC., USA, due to an increase in the interference

Device

Assay "Acetaminophen" reference 2K99-20, manufactured by Sekisui Diagnostics, LLC., USA.

Manufacturer

Sekisui Diagnostics, LLC.