Events

Recall of Access Peristaltic Pump a component of: Access and Access 2 Immunoassay Systems, SYNCHRON LX i 725 System, UniCel DxC 600i System, UniCel Dxl 800 Access Immunoassay Systems, UniCel Dxl 600 Access Immunoassay Systems and UniCel DxC 880i SYNCHRON Access Cl

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
    Recall
  • Event ID
    2008-0666
  • Date
    2008-10-03
  • Event Country
    Finland
  • Event Source
    VNSAWH
  • 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 - material / component.

Device

Access Peristaltic Pump a component of: Access and Access 2 Immunoassay Systems, SYNCHRON LX i 72...

Manufacturer

Beckman Coulter