Events

Retiro De Equipo (Recall) de COULTER LH 500 HEMATOLOGY ANALYZER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    135614
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-11-03
  • 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
    Follows recall number 59046 (beckman coulter update letter dated april 20 2011 pca-14994). two additional lots of lh series pak reagent kits were not identified in the last communication. excess r flags and incomplete or abnormal differential computation results with use of coulter 5c cell control abnormal ii may also be encountered with lh series pak reagent kits lots 110882k and 110883k.

Device

COULTER LH 500 HEMATOLOGY ANALYZER
  • Modelo / Serial
    Model Catalog: 178833 (Lot serial: ALL); Model Catalog: 178832 (Lot serial: ALL); Model Catalog: A91062 (Lot serial: ALL); Model Catalog: A90994 (Lot serial: ALL); Model Catalog: 178834 (Lot serial: ALL); Model Catalog: 6605525 (Lot serial: ALL); Model Catalog: 6605524 (Lot serial: ALL); Model Catalog: 6605522 (Lot serial: ALL); Model Catalog: 6605526 (Lot serial: ALL); Model Catalog: 6605527 (Lot serial: ALL); Model Catalog: A85564 (Lot serial: ALL); Model Catalog: A85566 (Lot serial: ALL); Model Catalog: 6605523 (Lot serial: ALL); Model Catalog: 6706000 (Lot serial: ALL); Model Catalog: 6705999 (Lot serial: ALL); Model Catalog: 6705998 (Lot serial: ALL); Model Catalog: 6705997 (Lot serial: ALL); Model Catalog: 6705996 (Lot serial: ALL); Model Catalog: 6705995 (Lot serial: ALL); Model Catalog: 6604687 (Lot serial: ALL); Model Catalog: 6604569 (Lot serial: ALL)
  • Descripción del producto
    COULTER LH 500 SERIES ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC