Events

Recall Or Safety Alert for Reagent Kit Access Free T3, reference A13422, used with the Access family of immunoassay systems (Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i and UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, UniCel DxC 660i

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 Beckman Coulter.

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
    2016-06-29
  • 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
    Cessation of the use of certain batches of the Access Free T3 reagent kit, reference A13422, manufactured by Beckman Coulter, USA, due to the fact that they show an upward change in the results of the patients.

Device

Reagent Kit Access Free T3, reference A13422, used with the Access family of immunoassay systems ...

Manufacturer

Beckman Coulter