Events

Recall of Beckman Coulter UniCel DxI and DxC Access Immunoassay Systems

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
    14153
  • Event Initiated Date
    2013-01-31
  • 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
    Improper tubing installation by the customer during routine maintenance may prevent the dxi and dxc systems from washing reaction vessels properly and may lead to erroneous test results., note - this matter was initiated in 2011 but was not advised as a recall action at the time. information received in retrospect following an audit of the manufacturer's capa files.
  • Action
    Product to be modified

Device

Beckman Coulter UniCel DxI and DxC Access Immunoassay Systems
  • Model / Serial
    Model: Models: DxI 800, DxI 600, DxC 660i, 680i, 860i, 880i, Affected: Specified serial number ranges
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc