Events

Recall of AQURE POC Management System, software versions 1.4.0 to 1.5.3 (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 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-2013-RN-00275-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00275-1
  • 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
    Patient results are displayed with the incorrect unit of measure in aqure when:a) aqure is changed from the default setting for any or all parameters of international system of units to use non-international system of units (si units); andb) the result is outside reference and critical ranges; andc) aqure is being used to view the results.Results on the analyser and reported to the his/lis remain correct.
  • Action
    End users are advised to view patient results in their HIS/LIS system and not in AQURE POC management system. Radiometer will provide an update to software version1.5.4 to correct this issue.

Device

AQURE POC Management System, software versions 1.4.0 to 1.5.3 (An in vitro diagnostic medical dev...
  • Model / Serial
    AQURE POC Management System, software versions 1.4.0 to 1.5.3 (An in vitro diagnostic medical device (IVD))
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd