Events

Alerta De Seguridad O Notificaciones De Seguridad para Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser

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 Roche.

¿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/2014/012
  • Número del evento
    CON406356
  • Fecha
    2014-04-16
  • Fecha de publicación del evento
    2014-04-16
  • 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/CON406356?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
    The level sensing function of the cobas c502 laboratory analyser has not been activated for tests requiring manual reagent handling. the use of insufficient volumes of reagent may lead to a false negative result and a missed diagnosis, such as syphilis. it is possible to obtain ‘valid’ but inaccurate results when there is no reagent remaining in the roche cassette. since we issued a notice in february 2012 (mda/2012/004) the settings for level sensing have not been correctly encoded in some rec files, therefore level sensing may not have been correctly performed on cobas c502 analysers.
  • Acción
    Follow the required actions set out in the manufacturer’s Field Safety Notice (FSN). If you have used the affected combination of devices, consider the need to review previous results and whether to recall and retest patients. Action by: Laboratory managers Directors of pathology GUM clinics.

Device

Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser
  • Modelo / Serial
  • Descripción del producto
    Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser made by Hitachi, supplied by Roche. Multiple tests are affected, including syphilis (TPLA) test made by Sekisui. All reagents are supplied by Roche. The analyser can run assays that are: manufactured by Roche manufactured by third parties and supplied by Roche – ‘partnership assays’ (eg TPLA) Affected assays include those requiring manual handling that are listed in the Roche Field Safety Notice
  • Manufacturer
    Roche

Manufacturer

Roche