Events

Recall of Beckman Coulter UniCell DxH 800 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
    15448
  • Event Initiated Date
    2013-09-27
  • 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 indicates that specific lots of check valves used in several locations with the lh750 and lh780 analysers may fail. this failure may result in an air or liquid leak at the vcs waste chamber or probe waste chamber.
  • Action
    Product to be modified

Device

Beckman Coulter UniCell DxH 800 Cellular Analysis system
  • Model / Serial
    Model: Product Number: 629029, Affected: Selected serial numbers
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc