Events

Recall of iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

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
    RC-2015-RN-00671-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00671-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The ichemvelocity systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees celsius at 20-80% relative humidity (rh) as stated in the ichemvelocity product labelling. the on-board strip stability is affected by temperature and humidity in your laboratory. test results may be affected as indicated below:false low or false negative results: ketone, bloodfalse high or false positive results: bilirubin, urobilinogen, glucose, nitritefalse high results: leukocytesascorbic acid, protein and ph are not affected.
  • Action
    Beckman Coulter is providing an updated stability guide and additional handling instructions to ensure the stability of the test strips. The manufacturer, Iris International, has determined that the Strip Provider Module is not maintaining the humidity levels associated with the original on-board strip stability claim and is urgently developing a corrective action. This action has been closed-out on 06/09/2016.

Device

iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips
  • Model / Serial
    iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry StripsStrip part numbers 800-7204 and 800-7204-001
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd