Events

Recall of Beckman Coulter UniCel DxH 600 & DxH 800 Cellular Analysis Systems

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
    15774
  • Event Initiated Date
    2013-11-29
  • 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
    Complaints related to optical degradation have increased on the dxh 800 and dxh 600 systems. customers have reported that they are experiencing an increase in one or more of the following:, * flow cell clogs (: : ::), * ls offset errors during daily check or control analysis, * high coefficients of variation (cv) for latron cp-x controls for low angle light scatter (lals) and/or axial light loss (all) parameters, * system messages and r-flagged results for nrbc, diff and retic during control or patient analysis, such as partial clogs (low event rated with diff rs) or a voltage failure (system event: d with diff rs).
  • Action
    Instructions for use to be updated

Device

Beckman Coulter UniCel DxH 600 & DxH 800 Cellular Analysis Systems
  • Model / Serial
    Model: Part Numbers: B23858 & 629029, Affected:
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc