Events

Rappel de RIA Coat-A-Count Androstenedione

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

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-00624-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-11
  • 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-00624-1
  • 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
    Siemens healthcare diagnostics has received complaints regarding the coat-a-count direct androstenedione assay demonstrating a higher frequency of results >10 ng/ml (>25 nmol/l) compared to alternate platforms. through internal investigation siemens has determined that there is a potential of cross-reactivity in circulating physiological serum levels up to 8.82% detected with spironolactone and its two metabolites, canrenone and 7a-thiomethyl spironolactone with the ria cac direct androstenedione assay. the degree of cross-reactivity is dependent on the circulating dose in the patients’ serum.
  • Action
    Siemens is advising pathology laboratories that the assay should not be used on patients being treated with spironolactone due to cross reactivity. These patients should be tested using an alternative method. A look back using another test method may be required if a patient has been administered spironolactone.

Device

RIA Coat-A-Count Androstenedione
  • Modèle / numéro de série
    RIA Coat-A-Count AndrostenedioneCatalogue Number: TKAN1Siemens Material Number: 10381049Lot Numbers: 587 and aboveARTG Number: 210100
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA