Events

Notificaciones De Seguridad De Campo acerca de Clearview HCG 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 Unipath Limited.

¿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
    SN2007(02)
  • Fecha
    2007-06-12
  • 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=/clearview-hcg-pregnancy-test-kit&id=e099f825-9782-6eee-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
    Lot hg0050 of the clearview hcg pregnancy test kit (cat number 500158) has been recalled by the manufacturer due to the potential for false negative results i.E. a negative result obtained in pregnancy.
  • Acción
    Action or Recommendations for Healthcare Professionals Ensure that all relevant staff in your institution are informed of this recall   Determine if you have lot number HG0050 of the above product Locate and cease using product from lot number HG0050   Determine how much of this product has been used   Follow the distributor / manufacturer recommendations for quarantine and disposal of product Follow up patients as required Action or Recommendations for Patients Patients who have had a recent pregnancy test in hospital but are concerned that the negative result received may be incorrect should contact or seek a retest from their GP, family planning clinic or pharmacist.

Device

Clearview HCG Pregnancy Test Kit
  • Modelo / Serial
  • Descripción del producto
    Clearview HCG Pregnancy Test Kit
  • Manufacturer
    Unipath Limited

Manufacturer

Unipath Limited
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HPRA