Recall of UniCel Dxl Access Immunoassay System (Part Number 973100) With: UniCel Dxl 800 Modification (MOD ID 10027) and/or UniCel Dxl Modification (MOD ID 6733)

According to Valvira - National Supervisory Authority for Welfare and Health (via FOI), this recall involved a device in Finland that was produced by Beckman Coulter.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Notes / Alerts
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Extra notes in the data
    Source: MDV IE
  • Reason
    Device failure / feature before use - design.