Events

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

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
    35426
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-12-14
  • 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
    Following an assessment of etest teicoplanin with staphylococcus spp. it has been observed that even though the mic essential agreement at +/- 1 dilution is les than 95% between etest tp256 and the reference method agar dilution (ad) for staphylococcus spp. an underestimation of mic values by at least 1 dilution has been observed for coagulase negative staphylococci (cons). this underestimation leads to a risk of false susceptible results linked in particular to the lack of an intermediate category interpretation if eucast breakpoints are applied for this antibiotic. during the study the false susceptible rate observed was 37.5% for cons where strains with an mic at 8 mg/ml by the reference method (resistant) can be found susceptible by etest teicoplanin.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - TEICOPLANIN
  • Modelo / Serial
    Model Catalog: 522018 (Lot serial: More than 10 lots-contact man.); Model Catalog: 412461 (Lot serial: More than 10 lots-contact man.)
  • Descripción del producto
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - TEIC
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.