Recall of Beckman Coulter iChem VELOCITY Automated Urine Chemistry System using iChem VELOCITY Urine Chemistry Strips

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
  • Event ID
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Customer complaints have been received indicatiing loose or missing analyte pads for the ichem velocity urine chemistry strips. this may result in false negative results for any analyte(s) or false low or false high ph, but does not apply to the color, clarity and specific gravity which is analyzed through a different mechanism and module. hazardous situation is a potential erroneous result received by a physician.
  • Action
    Manufacturer to issue advice regarding use


  • Model / Serial
    Model: 800-7204, 800-7204FJR, Affected: all lots
  • Manufacturer