Events

Recall of UniCell DxH600 UniCell DxH800 DxH SMS

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Beckman Coulter Inc.

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
    20028
  • Event Initiated Date
    2016-04-18
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Reason
    The dxh 800, dxh 600, and dxh slidemaker stainer may fail to notify the user via the alert icins, audible alarm, and instrument beacon, for daily check failures, lis disconnects printer failurees and reagent container low/depleted notifications.
  • Action
    Software to be upgraded

Device

UniCell DxH600 UniCell DxH800 DxH SMS
  • Model / Serial
    Model: 629029, B24465, B24802,B68304 B23858 and 775222, Affected: , Software version: DxH 800/SMS 3.0.2.0 and DxH 600 1.1.1.0 released in June 2015
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc