Events

Recall of AQT90Flex TnI (troponin) Test Kit. 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-2014-RN-01304-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01304-1
  • 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 risk of receiving a false high result when using the aqt90 flex tni test kit, 942-903, lot 09619. it has been reported that calibration adjustment cups may have been packed into the tni test kit cartridges of this lot. thus, in some test cartridges, one or more cups may be a calibration adjustment cup instead of a test cup.Patients receiving the erroneous result may be diagnosed as having an acute myocardial infarction and may immediately be subjected to standard treatment for this disease (such as surgical intervention percutaneous transluminal coronary angioplasty or treatment with fibrinolytic or other drugs). subsequent normal measurements of tni should result in recognition of the erroneous diagnosis and termination of the wrongful treatment.
  • Action
    Radiometer are advising their customers to: 1. Check inventory and remove all AQT90 FLEX TnI Test Kit Boxes of the affected lot 09619; 2. Discard all affected stock; and 3. Review any patient results, in conjunction with the Medical Director, where affected test kits are known to have been used.

Device

AQT90Flex TnI (troponin) Test Kit. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    AQT90Flex TnI (troponin) Test Kit. An in vitro diagnostic medical device (IVD).Item : 942-903Lot Number: 942-90309619ARTG Number: 224526
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd