Events

Recall of Radiometer AQT90Flex Troponin 1 kit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Radiometer Medical ApS.

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
    17858
  • Event Initiated Date
    2014-12-17
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • 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.
  • Action
    Product to be destroyed

Device

Radiometer AQT90Flex Troponin 1 kit

Manufacturer

Radiometer Medical ApS