Events

Alerta De Seguridad O Notificaciones De Seguridad para Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption, Alegria Anti-Intrinsic Factor Assay (ORG-247-24)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Orgentec Diagnostika GmbH.

¿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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/041
  • Número del evento
    CON286935
  • Fecha
    2013-06-19
  • Fecha de publicación del evento
    2013-06-19
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286935?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Deterioration in the activity of affected lots may lead to false negative results outside of the manufacturer’s claims for performance (61.2% sensitivity). a false negative could result in a delay in diagnosis or treatment of vitamin b12 malabsorption. laboratory internal quality control systems may not detect this deterioration. orgentec issued a product notification letter in which they mention a further lot - 24723945 (expiry 28/02/2014). this lot has also shown a deterioration in activity in a recent uk neqas haematinics distribution.
  • Acción
    Do not use devices from the affected lot. Consider the need to review previous negative results from tests performed using the affected lot. Where results are inconsistent with the clinical picture, samples should be retested with a different lot number. It may be necessary to arrange for repeat samples. Contact Launch Diagnostics (01474 876 402) to request replacement strips for retesting. Clinical pathologists Biomedical scientists

Device

Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption, Alegria Anti...
  • Modelo / Serial
  • Descripción del producto
    Laboratory test kit: Intrinsic Factor Antibody test strips used in testing for vitamin B12 malabsorption. Alegria Anti-Intrinsic Factor Assay (ORG-247-24) lot number 24723031 expiry 30/11/2013.
  • Manufacturer
    Orgentec Diagnostika GmbH

Manufacturer

Orgentec Diagnostika GmbH