Events

Alerta De Seguridad O Notificaciones De Seguridad para Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing

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 N/A.

¿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/2013/012
  • Número del evento
    CON249673
  • Fecha de publicación del evento
    2013-03-19
  • 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/CON249673?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
    Health canada (the canadian regulatory authority for medical devices) has suspended sale of these kits in canada due to concerns about the manufacturer’s quality systems – see: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/23151a-eng.Php health canada's decision to suspend these licences is not based on an identified issue with the safety and effectiveness of any particular device. the mhra has not received any reports of adverse incidents in the uk involving these devices. the product is currently still available for use in the uk the mhra is continuing to monitor this situation.
  • Acción
    Users should report any incidents of false results involving these products to the MHRA and the supplier, to enable the MHRA to monitor the situation in the UK. Note: the MHRA will consider the need to issue further advice based upon information received from UK users. Healthcare personnel treating patients based on results from test strips. Healthcare personnel using, supplying, supervising, quality assuring or distributing these test strips.

Device

Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opi...
  • Modelo / Serial
  • Descripción del producto
    "Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing, manufactured by: IND Diagnostics Inc, Canada Alere International Ltd Barrier Healthcare Ltd E-Pharm Ltd The table below lists test strips that have been supplied in the UK between January 2011 and March 2013 Manufacturer Device Type Device Name IND Diagnostics Urinalysis Reagent Test Strips Urinalysis Reagent Test Strips IND Diagnostics HCG Pregnancy Test Indicator One-Step Urine Pregnancy Test (Cassette Format) Indicator One-Step Urine Pregnancy Test (Ministrip Format) Indicator One-Step Home Pregnancy Test (Midstream Format) Indicator One-Step Home Pregnancy Test (Mini-Midstream Format) IND Diagnostics FSH Menopause tests One Step FSH Menopause Test (Strip Format) One Step FSH Menopause Test (Cassette Format) One Step FSH Menopause Test  (Midstream Format) IND Diagnostics Opiates Test IND One Step Opiates Test Alere International Ltd. HCG Pregnancy test Axis Shield Pregnancy test dipstick and cassette Barrier Healthcare Ltd Urinalysis Reagent Test Strips DIA-CHECK Urinalysis Reagent Strips E-Pharm HCG Pregnancy Test PREGTEST (Strip format) PREGTEST (Cassette format) PREGTEST (Midstream format)"
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    MHRA