Events

Recall of Radiometer immunoassay AQT90FLEX Analyser

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific 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-00273-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00273-1
  • 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
    Radiometer has recently become aware of a potential significant clinical issue where a measured parameter with a positive result may be reported as being negative.The problem may occur in rare situations where the analyser uses an incorrect hct value equal to 0% possibly due to:· incorrect needle calibration in wash block after change of hct cell. · needle not sufficiently tightened after replacement. insufficient cleaning causing disrupted flow in the fluid path between wash block and needle. · air bubbles in the sample due to use of a different sample tube than recommended.
  • Action
    A Radiometer Pacific representative will perform a test to determine if the analyser is affected and perform a correction to eliminate the risk. A software update is under development that will include an analysis process check to eliminate the possibility of this error. End users are requested to ensure that the mandatory ‘System Clean’ is performed regularly as instructed in the AQT90FLEX Instructions For Use. This action has been closed-out on 26/08/2016.

Device

Radiometer immunoassay AQT90FLEX Analyser
  • Model / Serial
    Radiometer immunoassay AQT90FLEX AnalyserARTG Number: 224867An in vitro diagnostic medical device (IVD).
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd