Events

Retiro De Equipo (Recall) de ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AGILENT TECHNOLOGIES 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
    80210
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-06-09
  • 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
    Four customer complaints were received for one lot of ar176 artisan grocott's methenamine silver (gms) stain kit regarding fungal looking organisms appearing after staining particularly on the periphery of slides away from the stained tissue. the contaminate was confirmed to be fungal most likely common indoor mold wallemia sebi and was confined to one reagent supplied by an outside vendor. artisan grocott's methenamine silver (gms) stain kit is indicated for identifying fungal organisms including pneumocystis jirovecii. the contamination could potentially compromise the device's diagnostic effectiveness.

Device

ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN KIT
  • Modelo / Serial
    Model Catalog: AR176 (Lot serial: 10095053)
  • Descripción del producto
    ARTISAN GROCOTT'S METHENAMINE SILVER (GMS) STAIN KIT
  • Manufacturer
    AGILENT TECHNOLOGIES CANADA INC.

Manufacturer

AGILENT TECHNOLOGIES CANADA INC.