Events

Recall of UniCel DxI 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
    21467
  • Event Initiated Date
    2017-05-24
  • 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
    The manufacturer has determined through customer feedback and an internal investigation that the four access immunoassays are susceptible to biotin interference. during interference testing the interference occurred with samples that contained 100 ng/ml of biotin. this level of biotin is greater than the maximum biotin concentration observed in the normal healthy population.
  • Action
    Manufacturer to issue advice regarding use

Device

UniCel DxI System
  • Model / Serial
    Model: , Affected: Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor All Lots
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc