Events

Recall of Radiometer AQT90FLEX Immunoassay analyser. 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-2017-RN-01195-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01195-1
  • 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 that the internal temperature in the aqt90 flex analyser under worst case conditions may slightly exceed acceptable storage conditions for aqt90 flex on-board test cartridges.Please note that if the aqt90 is exposed to temperatures above the new limit, but still within the old limits, the cartridges are still safe to use. the specifications are only affected with a few % and this is below any clinical significance. no action is required regarding the cartridge.To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the aqt90 flex analyser has been adjusted to 30°c/86.0°f (down from 32°c/89.6°f).
  • Action
    1. To ensure that the temperature does not exceed maximum limit, the environmental specifications for the ambient temperature for the AQT90 FLEX Analyser has been adjusted to 30°C (down from 32°C). 2. For users: a. If the ambient temperature is above 30°C r reduce it to below 30°C or move the analyser to another location that is below 30°C b.Complete and return the supplied Customer Reply form, within 7 days from receipt, to acknowledge this notification and implementation of the required actions. c. If you are not the end user of the affected product please ensure that this letter is distributed to the final end user. 3. Radiometer will contact users to arrange a suitable time for a Radiometer representative to install a software upgrade V8.9.613.0 or higher. This software upgrade will reduce the heat generated internally and distribute the heat generated more evenly. 4. Users will also be provided with a revised copy of the Instructions For Use (IFU).

Device

Radiometer AQT90FLEX Immunoassay analyser. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Radiometer AQT90FLEX Immunoassay analyser. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Number: 224867
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd