Events

Recall of ichem VELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD).

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-01092-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01092-1
  • 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
    Beckman coulter has become aware of a manufacturing defect where multiple strips with multiple missing pads were found inside the strip vial for the affected lot number. if the affected strips are used, it may result in quality control failures and potential false negative results for any or all analytes and erroneous ph results if affected strips are used to assay patient samples.
  • Action
    Beckman Coulter is advising users to discard affected lots. Any affected lots will be replaced by unaffected product. Beckman Coulter is advising users to consult with the Laboratory Director to determine if a retrospective review of results is clinically warranted. This action has been closed-out on 18/08/2016.

Device

ichem VELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    ichem VELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD). Reference Number: 800-7204Lot Number: 7204089B ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd