Events

Recall of DxH500 open-Vial Hematology System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Beckman Coulter Ireland 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
    22229
  • Event Initiated Date
    2017-11-08
  • 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
    An internal investigation has identified that if the bleach cycle is interrupted or aborted, the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted, the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected.
  • Action
    Software to be upgraded

Device

DxH500 open-Vial Hematology System

Manufacturer

Beckman Coulter Ireland Inc