Events

Alerta De Seguridad O Notificaciones De Seguridad para ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc

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 Oxoid Ltd.

¿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
  • Número del evento
    MDA/2017/034
  • Fecha
    2017-11-23
  • Fecha de publicación del evento
    2017-11-23
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/thermoscientifictm-oxoidtm-caz10-ceftazidime-ct1629b-antimicrobial-susceptibility-test-disc-potential-for-false-resistance-results-if-stored-at-the-wrong-temperature
  • 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
    Manufactured by oxoid ltd (thermofisher scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°c and 8°c: only specific lots are affected (mda/2017/034).
  • Acción
    Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice (FSN) and that they understand the problem and the actions to be taken. Destroy all affected lots (listed in the FSN) and contact Thermo-Fisher customer services / local distributor for replacements. Discs that have been stored between -20°C and 2°C remain unaffected for the entire shelf life (36 months). If concerns exist after repeat testing, alternative methods of establishing ceftazidime susceptibility should be used. As part of your review processes, report any incorrect results to MHRA via Yellow Card or the relevant devolved administration.

Device

ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc

Manufacturer

Oxoid Ltd
  • Dirección del fabricante
    Martyn Rogers Thermofisher Scientific Wade Road Basingstoke RG24 8PW Telephone: 01256 694 245martyn.rogers@thermofisher.com
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    MHRA