Events

Retiro De Equipo (Recall) de DXH 500

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
    144731
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-11-07
  • 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
    Beckman coulter has determined that if the bleach cycle is interrupted or aborted the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected. patient results may be impacted due to residual bleach in the diluter when a sample is processed immediately after a bleach cycle is interrupted.

Device

DXH 500
  • Modelo / Serial
    Model Catalog: B40601 (Lot serial: AZ120651); Model Catalog: B40601 (Lot serial: AZ120636); Model Catalog: B40601 (Lot serial: BA070451); Model Catalog: B40601 (Lot serial: BA060399); Model Catalog: B40601 (Lot serial: AZ120657); Model Catalog: B40601 (Lot serial: AZ120656); Model Catalog: B40601 (Lot serial: AZ120655); Model Catalog: B40601 (Lot serial: AZ110582); Model Catalog: B40601 (Lot serial: BA070450); Model Catalog: B40601 (Lot serial: AZ060306); Model Catalog: B40601 (Lot serial: 1.0.2 and 1.1); Model Catalog: B40601 (Lot serial: AZ030171); Model Catalog: B40601 (Lot serial: BA060398)
  • Descripción del producto
    DXH 500 OPEN-VIAL HEMATOLOGY SYSTEM
  • 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