Events

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

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
    73372
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-03
  • 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 qc failures (mic out of range high) for s.Aureus atcc 29213 strain on etest ox 256 (oxacillin) foam packaging (ref. 520518) reported from the field biomerieux initiated a complaint investigation to confirm product issue and determine root cause. the investigation confirmed a potential performance issue for s. aureus atcc 29213 qc strain and clinical staphylococcus strains on etest? ox 256 (oxacillin) foam packaging (ref. 520518) whatever the media used when compared to the agar dilution reference method that could lead to false resistant results. the investigation states that etest? ox 256 (oxacillin) spb configuration (ref.412432) performs within the expected specifications. as a result of the referenced issue there is a potential performance issue on strain categorization for staphylococcus strains that could lead to major errors when compared to the ad (agar dilution) reference method (resistant result instead of susceptible result) when using 2017 clsi or 2017 eucast standards.

Device

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - OXACILLIN
  • Modelo / Serial
    Model Catalog: 520518 (Lot serial: 1004319590); Model Catalog: 520518 (Lot serial: 1004070580); Model Catalog: 520518 (Lot serial: 1004818850); Model Catalog: 520518 (Lot serial: 1003055340); Model Catalog: 520518 (Lot serial: 1003315740)
  • Descripción del producto
    ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - OXAC
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.