Events

Alerte De Sécurité sur Pregnancy test "ROMED - HCG test".

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ROMED - Van Oostveen Medical B.V..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    686
  • Date
    2002-11-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT INCLUDE REGISTRATION OF THE PRODUCT IN BRAZIL.
  • Cause
    The in-vitro diagnostic medical device for self-diagnosis "romed - hcg test", manufactured by the dutch company romed - van oostveen medical bv and distributed by imporfar, lda., is being marketed in the portuguese market with ce marking, without has been evaluated by a notified body responsible for assessing the conformity of the device with the european directive 98/79 / ec together with other non-conformity with the labeling and package leaflet.
  • Action
    The self-diagnostic device "ROMED - HCG Test", manufactured by the Dutch company ROMED - Van Oostveen Medical BV, does not have the certificate mentioned above and is in a situation of unduly affixing the CE marking. Therefore, INFARMED Pharmacy and Medicinal Products), as Competent National Authority (Portugal) for Medical Devices for In Vitro Diagnosis, decided to withdraw from the national market.

Device

Pregnancy test "ROMED - HCG test".

Manufacturer

ROMED - Van Oostveen Medical B.V.
  • Source
    ANVSANVISA