Events

Recall of Beckman Coulter Unicel DxH 600 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
    19546
  • Event Initiated Date
    2015-12-09
  • 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
    During internal testing, beckman coulter determined that the software for specific systems allows the creation of multiple orders with the same specimen identification (id) but different patient identification when manually editing pending orders at the system manager. the issue does not occur for edits of released results or for test orders requested through host transmission.
  • Action
    Software to be upgraded

Device

Beckman Coulter Unicel DxH 600 Cellular Analysis System
  • Model / Serial
    Model: B23858, Affected: , Software version: 1.1.1.0
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc