Events

Retiro De Equipo (Recall) de THINPREP 2000

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por HOLOGIC 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
    31592
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-06-24
  • 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
    Hologic has recently been notified by health canada regarding classification of the thinprep 2000 and thin prep 5000 processors. these products entered the canadian market as class i devices and it has been determined that these should be classified as class iii. this reclassification is the result of an administrative error and is completely unrelated to the safety and effectiveness of the thin prep processors. there are no issues or concerns with the safe and effective use of the thin prep 2000 or the thin prep 5000 processors and the integrity of all past current and future tests are not in question.

Device

THINPREP 2000
  • Modelo / Serial
    Model Catalog: 70031-001 (Lot serial: All lots); Model Catalog: 70031-002 (Lot serial: All lots); Model Catalog: 71362-001 (Lot serial: All lots); Model Catalog: 71362-002 (Lot serial: All lots)
  • Descripción del producto
    ThinPrep 2000 Processor
  • Manufacturer
    HOLOGIC INC.

Manufacturer

HOLOGIC INC.
  • Dirección del fabricante
    MARLBOROUGH
  • Empresa matriz del fabricante (2017)
    Hologic, Inc.
  • Source
    HC