Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01316-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01316-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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