Events

Recall of iChemVELOCITY Urine Chemistry Analyzers

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
    22701
  • Event Initiated Date
    2018-03-08
  • 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 that there is a potential for incorrect settings to be installed on north american ichemvelocity urine chemistry analyzers., the installation of international settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations., the installation of colours differ from those stated in the instructions for use (colourless, straw, yellow, amber, red, blue) for output settings will result in incorrect reporting of colours. for example, if green is the colour choice for the output setting instead of blue, green will be reported.
  • Action
    Software to be upgraded

Device

iChemVELOCITY Urine Chemistry Analyzers
  • Model / Serial
    Model: , Affected: All Instruments with North America System Configuration Settings
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc