Events

Recall of iChemVELOCITY Automated Urine Chemistry Systems. 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-2017-RN-00170-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00170-1
  • 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 manufacturer, iris international, has determined that sample probe misalignment or bending on the ichemvelocity may lead to a remote possibility of false negative results due to inadequate strip dosing. inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. incorrect patient results might be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. the greatest impact could occur when proteinuria is not detected. a control failure could indicate inadequate dosing caused by probe bending/misalignment that occurred due to probe mishandling during maintenance or troubleshooting, or through use of an incorrect tube type or placement on the system.
  • Action
    The manufacturer has designed a Pipette Mounting Block that will better secure the probe, avoiding misalignment and bending. A Beckman Coulter representative will contact customers to schedule a service visit for implementation. In the interim, the following actions are recommended: - Avoid bumping the probe during maintenance or troubleshooting. - Carefully follow instructions in your Operator’s Manual, PN 301-7146 or 300-4449, for utilising the Pipette Safety Parking Device, using the approved tube types, and removing tube caps before sample analysis to avoid probe-tube collisions. - Perform a patient cross check or run quality control after performing maintenance or troubleshooting in the probe area. If there are concerns with the results, contact Beckman Coulter. - Consult with the Laboratory Director to determine whether a retrospective review of results is clinically warranted.

Device

iChemVELOCITY Automated Urine Chemistry Systems. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    iChemVELOCITY Automated Urine Chemistry Systems. An in vitro diagnostic medical device (IVD).Model Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061All Serial NumbersARTG Number: 181116
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd