Events

Retiro De Equipo (Recall) de ASP6025 TISSUE PROCESSOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por LEICA BIOSYSTEMS NUSSLOCH GMBH.

¿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
    19501
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-08-10
  • 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
    One complaint was received from a customer in spain where poor processing was identified and samples were deemed non-diagnosable. the investigation of the unit when returned to the manufacturer on july 15th led to a safety meeting which determined that the instrument is incorrectly getting into a state of "bottle empty" during retort filling after passing the fill lever sensor 2 and prior to reaching level sensor 3 thus not completing a 5 litre fill.

Device

ASP6025 TISSUE PROCESSOR
  • Modelo / Serial
    Model Catalog: ASP6025 (Lot serial: 316); Model Catalog: ASP6025 (Lot serial: 448); Model Catalog: ASP6025 (Lot serial: 538); Model Catalog: ASP6025 (Lot serial: 594); Model Catalog: ASP6025 (Lot serial: 446); Model Catalog: ASP6025 (Lot serial: 622); Model Catalog: ASP6025 (Lot serial: 314)
  • Descripción del producto
    LEICA ASP6025 TISSUE PROCESSOR
  • Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH

Manufacturer

LEICA BIOSYSTEMS NUSSLOCH GMBH