Events

Recall of Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis 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 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
    20489
  • Event Initiated Date
    2016-08-09
  • 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
    Manufacturer has received and confirmed a report of a fire within the stainer module of a customer's dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module's methanol bath. beckman coulter is initiating this corective action to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire.
  • Action
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
  • Model / Serial
    Model: 775222, Affected: , Software version: all software revisions
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc