Events

Rappel de Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. 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 Thermo Fisher Scientific.

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-2014-RN-00155-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-13
  • 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-2014-RN-00155-1
  • 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
    Thermo fisher scientific would like to inform that the use of calibrator brahms free beta-hcg kryptor cal may result in a decreased free beta-hcg concentration for brahms gm kryptor qc as well as for patient samples by approximately 4%. this may lead to incorrect risk estimation of chromosomal anomaly of the foetus.
  • Action
    Thermo Fisher Scientific is advising users to stop use of the affected lot number. The affected lot will be replaces by a previous calibrator which may have a shorter expiry date. Thermo Fisher is recommending that results generated with the affected calibrator are re-evaluated in the context of other laboratory and clinical parameters and retest if required.

Device

Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)Lot Number: 09045Expiry Date: 16 October 2014Kit Reference Number: CDB80991
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific