Events

Notificaciones De Seguridad De Campo acerca de Clinitest® hCG Cassette Pregnancy Test Kit

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

¿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
    SN2011(33)
  • Fecha
    2011-12-19
  • 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=/clinitest-hcg&id=5580f825-9782-6eee-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
    Lots 028619, 028924, 029997, 030240, 030431, 030602, 030826, 030998, 031332, 031460, 031662, 031798, 031924, 032106 and 032180 of the clinitest hcg pregnancy test kits have been recalled by the manufacturer due to the potential for borderline or false positive results with commercially available controls and patient samples.
  • Acción
    ACTION OR RECOMMENDATIONS FOR HEALTHCARE PROFESSIONALS  • Ensure that all relevant staff in your institution are informed of this  recall  • Determine if you have lots 028619, 028924, 029997, 030240, 030431,  030602, 030826, 030998, 031332, 031460, 031662, 031798, 031924,  032106, and 032180 of the above product  • Locate and cease using product from the lots listed above  • Determine how much of this product has been used  • Follow the distributor / manufacturers recommendations for quarantine  and disposal of product  • Follow up with patients as required.  ACTION OR RECOMMENDATIONS FOR PATIENTS  • Patients who have had a recent pregnancy test administered by a healthcare  professional but are concerned that the positive result received may be  incorrect should contact or seek a retest from their GP, family planning  clinic or pharmacist.

Device

Clinitest® hCG Cassette Pregnancy Test Kit

Manufacturer

Siemens Healthcare Diagnostics
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HPRA