Events

Recall of iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in vitro diagnostic 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-2016-RN-00065-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00065-1
  • 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
    There have been complaints indicating that loose or missing analyte pads being found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the ichemvelocity system.If affected strips are used to assay patient samples, the issue has the potential to cause erroneous ph results and false negative results for the following tests:nitrite, glucose, blood, bilirubin, urobilinogen, protein, leukocyte esterase, ketones, and ascorbic acid.There is no impact to the measurement of colour, clarity and specific gravity.
  • Action
    The sponsor is advising users to discard the vial and not use the strips from that vial when loading strips if loose or missing analyte pads are observed. Users should contact the sponsor for product replacement. A review of patients' results is at the discretion of the laboratory director. This action has been closed-out on 16/02/2017.

Device

iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in ...
  • Model / Serial
    iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in vitro diagnostic device (IVD)Reference Numbers: 800-7212; 800-7212-001; 800-7204; 800-7204-FJRAll Lot and Serial Numbers are affectedARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd