Events

Retiro De Equipo (Recall) de LEUKOSURE ENUMERATION KIT

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
    69169
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-06-07
  • 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
    There is incorrect activity levels stated on the instructions for use labeling in the leukosure enumeration kit due to the inaccurate activity values provided by the supplier for the raw material ribo-nuclease a type iii-a utilized as a component of the leukosure stain reagent. the activity value for these lots is 3.25ku/ml as compared to 4ku/ml as stated in the product labeling. alteration of the staining enumeration of white blood cells (wbc) in blood component preparation might produce falsely high values of white blood cells in samples with high levels of residual rna. these high values may result in the the blood component being considered inappropriate for use in transfusions thereby reducing the availability of blood for transfusion procedures. the high values may also result in unnecessary reprocessing of the blood component.

Device

LEUKOSURE ENUMERATION KIT
  • Modelo / Serial
    Model Catalog: 175621 (Lot serial: 5621013K); Model Catalog: 175621 (Lot serial: 5621012K); Model Catalog: 175621 (Lot serial: 5621014K)
  • Descripción del producto
    LEUKOSURE ENUMERATION KIT
  • 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