Events

Retiro De Equipo (Recall) de ETEST® XM256 (Cefuroxime)

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Biomerieux SA.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    21145
  • Fecha de inicio del evento
    2017-02-23
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Causa
    Investigation confirmed a potential performance issue on strain categorization for streptococcus pneumoniae and for enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 clsi clinical standards only., for streptococcus pneumoniae on etest® xm256 (cefuroxime) foam and spb could lead to minor error on clinical strains:, o false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method, o false intermediate result instead of resistant results with bmd reference method, for enterobacteriaceae on etest® xm256 (cefuroxime) foam and spb could lead to minor error on clinical strains:, o false susceptible result instead of intermediate results with ad (agar dilution) reference method, o false intermediate result instead of resistant results with ad reference method.
  • Acción
    Manufacturer to issue advice regarding use

Device

ETEST® XM256 (Cefuroxime)
  • Modelo / Serial
    Model: , Affected: ETEST XM256 (Cefuroxime) WW SPB lot number1002884720, ETEST XM256 (Cefuroxime) WW SPB lot number 1003383650, ETEST XM256 (Cefuroxime) WW Foam lot number 1003075850, ETEST XM256 (Cefuroxime) WW Foam lot number 1003385930
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA