Events

Retiro De Equipo (Recall) de Cytomics FC 500 Flow Cytometry System with CXP Software

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Beckman Coulter 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
    48188
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0129-2009
  • Fecha de inicio del evento
    2007-10-11
  • Fecha de publicación del evento
    2009-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70964
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Automated Differential Cell Counter - Product Code GKZ
  • Causa
    Software error: this field action was initiated after beckman coulter determined that the cxp software does not refresh the dataset automatically under certain circumstances. the user documentation does not clearly state that the user should refresh the dataset after changes are made.
  • Acción
    Software error: A Product corrective Action (PCA) letter was mailed via US Postal Service on October 17, 2007 to all Cytomics FC 500 Flow Cytometry System with CXP Software accounts. This letter was entitled "URGENT: PRODUCT CORRECTIVE ACTION." Customers were informed that the user documentation does not clearly state that the user should refresh the dataset after changes are made. The letters provide the customers with an explanation and action to be taken whenever a protocol containing data is modified by making changes to cytosettings, regions or gates. Customer were instructed to review all data plots and results before reporting results out. any uncharacteristic patterns in the data or unexpected results must be verified by running Quality Control and if necessary, preparing new samples. In addition, customer were instructed to please share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Also they were asked to complete and return the an attached Customer Response Form within ten days. Customers with questions or concerns regarding the notification, could call Beckman Coulter Customer Service at 1-800-526-7694 in the United States or Canada. Outside the US and Canada, they were to contact their local Beckman Coulter Representative.

Device

Cytomics FC 500 Flow Cytometry System with CXP Software
  • Modelo / Serial
    Part Number: 626553; Software version 2.2
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Globally - United States and Canada
  • Descripción del producto
    Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Dirección del fabricante
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA