Events

Recall of Radiometer ABL800 series with FLEXQ module. 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-01316-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01316-1
  • 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 identified that the registration receipt received after placing a sampler in the flexq can be associated with a different sampler if the barcode quality on the receipt has been affected. this issue may occur in the following situation:1. the analyser is setup to use registration receipts providing a barcode to identify the sampler and thereby the patient result;2. the sampler is placed in the flexq and a registration receipt is printed from the analyser;3. the quality of the barcode on the receipt is poor due to improper handling/damage or poor print quality;4.The registration receipt is later scanned on the analyser to print the result and the analyser misinterprets the barcode; and/or5. in the event that the misinterpreted barcode matches that of a previous registration receipt printed on that analyser, the damaged registration receipt may be associated with the previous sampler.
  • Action
    Radiometer is advising users who are testing a sampler in the FLEXQ and printing a registration receipt to verify that the patient results and demographic information match. Radiometer is developing a software upgrade to change the registration receipt barcode to a more robust version to remove the possibility of the barcode being misinterpreted. Radiometer will notify users when the upgrade is available.

Device

Radiometer ABL800 series with FLEXQ module. An in vitro diagnostic medical device (IVD)

Manufacturer

Radiometer Pacific Pty Ltd