Events

Retiro De Equipo (Recall) de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFUROXIME

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BIOMERIEUX CANADA INC..

¿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
    23127
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-01-25
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    An analysis was performed on the essential agreement rate reflecting the mic result obtained by the product for a significant strains kit including enterobacteriaceae haemophilus and s. pneumoniae. species. then an additional analysis was done on the clinical categorization of the strains based on clsi guidance. the following have been identified: the investigation confirmed a potential performance issue on strains 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 that could lead to minor error on clinical strains :false susceptible result instead of intermediate results with bmd (broth micro dilution) reference method. false intermediate result instead of resistant results with bmd reference method _ for enterobacteriaceae on etest? xm256 (cefuroxime) foam and spb that could lead to minor error on clinical strains: false susceptible result instead of intermediate results with ad (agar dilution) reference method. false intermediate result instead of resistant results with ad reference method products perform within the specification when using the 2016 eucast guidelines.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFUROXIME
  • Modelo / Serial
    Model Catalog: 412305 (Lot serial: More than 10 contact manuf.); Model Catalog: 506918 (Lot serial: More than 10 contact manuf.)
  • Descripción del producto
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFU
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.