Events

Recall of Iris iChem Velocity Automated Urine Chemistry System

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
    18899
  • Event Initiated Date
    2015-07-28
  • 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
    Iris has confirmed the ichem velocity automated urine chemistry systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees c at 20-80% relative humidity as stated in the product labeling. the on-board strip stability is affected by temperature and humidity in the laboratory. if a laboratory operates outside of the defined parameters , test results may be affected as indicated below:, * false low or false negative results: ketone, blood, * false high or false positive results: bilirubin, urobilinogen, glucose, nitrite, * false high results: leukocytes, ascorbic acid, protein and ph are not affected.
  • Action
    Instructions for use to be updated

Device

Iris iChem Velocity Automated Urine Chemistry System
  • Model / Serial
    Model: 800-3042, 800-3043, 800-3044, 800-3075, 800-3076, 800-3564, 800-7100, 800-7101, 800-7102, 800-7103, 800-7106, 800-7157, 800-7162, 800-7163, 800-7166, Affected: Manufactured between Apr-2011 and Jun-2015
  • Manufacturer
    Iris International

Manufacturer

Iris International