Events

Recall of Beckman Coulter iChemVELOCITY Automated Urine Chemistry Systems

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Iris International.

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
    21075
  • Event Initiated Date
    2017-02-08
  • 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 sample probe misalignment or bending on the ichemvelocity may lead to a remote possibility of false negative results due to inadequate strip dosing. the investigation was initiated based on customer complaints for control failures.
  • Action
    Manufacturer to issue advice regarding use

Device

Beckman Coulter iChemVELOCITY Automated Urine Chemistry Systems
  • Model / Serial
    Model: , Affected: 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061
  • Manufacturer
    Iris International

Manufacturer

Iris International