Recall Or Safety Alert for UniCel® DxHTM 800 Coulter cell analysis system, reference 629029 and Coulter® cellular analysis system of the Unicel® DxHTM slide stainer, reference 082775222.

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 N/A.

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
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Description of the Safety Notes that remain in force and that affect the UniCel DxH 800 Coulter Cell Analysis Systems and new information on a possible incidence in the use of the Sarstedt S-Monovette® tubes in the DxH system.


  • Source