Events

Rappel de QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). 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-01084-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-19
  • 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-01084-1
  • 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
    The manufacturer has determined that the affected lot may yield over-quantitation in patient samples. the manufacturer has conducted an internal assessment of product performance, and determined that over-recovery of whole blood assay results in the sub-therapeutic range by as much as 50% (for example, a reported assay result of 3.75 ng/ml instead of the actual whole blood concentration of 2.5 ng/ml). given standardised medication toxicity and close monitoring of patients for markers of efficacy, the risk of developing serious or long-range adverse health consequences due to a single reported erroneous everolimus concentration result is deemed to be negligible.
  • Action
    Thermofisher is advising users to discontinue use and destroy any remaining stocks of the affected batch. A credit note will be issued for the affected product. A review of previously generated results should be considered by the laboratory director and treating physician.

Device

QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). An i...
  • Modèle / numéro de série
    QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). An in vitro diagnostic medical device (IVD)Catalogue Number: 0373852Lot Number: 72258007Expiry Date: 31 July 2017ARTG Number 235822
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific