Events

Avis De Sécurité sur VITROS® Immunodiagnostic Products Estradiol Reagent Packs

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Ortho Clinical Diagnostics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Ortho clinical diagnostics (ortho) was made aware of the potential for medications that are derivatives of estrogen (e.G. fulvestrant, brand name: faslodex®) to interfere with estradiol immunoassays and cause positively biased sample results. due to this issue, we are initiating this field safety corrective action. fulvestrant is an estrogen receptor antagonist medication that blocks estrogen from tumors. the drug is used in the treatment of patients with metastatic, postmenopausal, hormone receptor-positive breast cancer. .

Device

VITROS® Immunodiagnostic Products Estradiol Reagent Packs

Manufacturer

Ortho Clinical Diagnostics