Events

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

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
    87481
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-06
  • 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
    Based on the strain epidemiology evolution with the detection of some streptococcus resistant strains from clinical specimens (around 1 and 5% according to clsi breakpoints) that did not exist at the moment of the product registration and as a part of the etest etp32 change impact study biomerieux initiated an internal study. the investigation results confirmed a potential performance issue on strain categorization for s. viridans group and s. pneumoniae based on 2017 clsi and eucast breakpoints that could lead to false susceptible result instead of resistant results on etest? etp32 (ertapenem) blister packaging when comparing to the broth-micro dilution (bmd) reference method. this performance issue was not evaluated at the time of product registration because rare or no resistant strains were reported at this time.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTAPENEM
  • Modelo / Serial
    Model Catalog: 531600 (Lot serial: More than 10 contact manuf.)
  • Descripción del producto
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - ERTA
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.