Events

Notificaciones De Seguridad De Campo acerca de Illegal “iCARE” self test kits

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Future Ventures Ltd.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2014(25)
  • Fecha
    2014-05-15
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/illegal-icare-self-test-kits.-priority-2-warning&id=17cff925-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    The icare hiv 1&2, icare syphilis, icare gonorrhea and icare chlamydia rapid screen self-test kits do not bear the ce mark, as required in europe. they are being sold illegally. these tests for sexually transmitted infections (stis) either have no ce mark, have no legal ce mark, or bear a fake ce mark.
  • Acción
    The IMB advises the public:  1) Do not buy or use the iCARE HIV 1&2, iCARE Syphilis, iCARE Gonorrhea or iCARE Chlamydia rapid screen self-test kits sourced either on-line or from any shop / supplier.  2) Contact your GP or pharmacist if you have (or think you may have) purchased or used an iCARE self-test STI kit. If affected, consider the need to re-test.  3) Do not buy medical devices from websites that you have not verified.  The IMB advises that healthcare professionals:  1) Notify the IMB of any suspected or confirmed incidents of patients having purchased and/or used iCARE HIV 1&2, iCARE Syphilis, iCARE Gonorrhea or iCARE Chlamydia rapid screen self-test kits.  2) Advise affected patients of the need to re-test.

Device

Illegal “iCARE” self test kits
  • Modelo / Serial
  • Descripción del producto
    Illegal “iCARE” self test kits. Priority 2 – Warning
  • Manufacturer
    Future Ventures Ltd

Manufacturer

Future Ventures Ltd
  • Source
    HPRA