Events

Retiro De Equipo (Recall) de LEICA PELORIS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LEICA MICROSYSTEMS 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
    29078
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-02-11
  • 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
    1. if during a manual bottle change the reset button is pressed with out actually changing the reagent the instrument will interpret the reset as fresh reagent being loaded and then use the reagent in the final tissue-processing step. the use of a degraded reagent in the final processing step can cause or contribute to tissue becoming unfit for diagnosis and if additional tissue is unavailable a rebiopsy may be required. 2. if a non-validated protocol is used or validated protocol is used inappropiately (i.E. wrong tissue sizetype or duration) this can cause or contribute to tissue becoming unfit for diagnosis and if additional tissue is unavailable a re-biopsy may be required.

Device

LEICA PELORIS
  • Modelo / Serial
    Model Catalog: 26.0001 (Lot serial: 0260095B); Model Catalog: 26.0001 (Lot serial: 0260097B); Model Catalog: 26.0001 (Lot serial: 0260109B); Model Catalog: 26.0001 (Lot serial: 0260114B); Model Catalog: 26.0001 (Lot serial: 0260118B); Model Catalog: 26.0001 (Lot serial: 0260144B); Model Catalog: 26.0001 (Lot serial: 0260163B); Model Catalog: 26.0001 (Lot serial: 0260178B); Model Catalog: 26.0001 (Lot serial: 0260190B); Model Catalog: 26.0001 (Lot serial: 0260295B); Model Catalog: 26.0001 (Lot serial: 0260035B); Model Catalog: 26.0001 (Lot serial: 0260043B); Model Catalog: 26.0001 (Lot serial: 0260009B); Model Catalog: 26.0001 (Lot serial: 0260300B); Model Catalog: 26.0001 (Lot serial: 0260038B)
  • Descripción del producto
    LEICA PELORIS RAPID TISSUE PROCESSOR
  • Manufacturer
    LEICA MICROSYSTEMS INC.

Manufacturer

LEICA MICROSYSTEMS INC.
  • Dirección del fabricante
    BUFFALO GROVE
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC