Events

Rappel de B.R.A.H.M.S Free BhCG Kryptor Kit. 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-2016-RN-00223-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-01
  • 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-2016-RN-00223-1
  • 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 has confirmed that the affected lots observe an overestimation of approximately 10% of free bhcg concentration in diluted samples or controls. undiluted samples and controls are not affected by the issue.The dilution of samples may lead to incorrect risk estimation for foetal chromosomal abnormalities. a patient may be considered at higher risk for trisomy 21 or at lower risk for trisomy 13/18.
  • Action
    ThermoFisher Scientific is advising users that the affected lot can continue to be used for undiluted samples only. The affected lot should be discarded once the replacement product has been provided. This action has been closed-out on 09/05/2017

Device

B.R.A.H.M.S Free BhCG Kryptor Kit. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    B.R.A.H.M.S Free BhCG Kryptor Kit. An in vitro diagnostic medical device (IVD)Kit Reference Number: 809.075Lot Numbers: 09075 and 09073 ARTG Number: 199700
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific