Events

Retiro De Equipo (Recall) de Device Recall Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager

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
    46370
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1529-2008
  • Fecha de inicio del evento
    2007-08-20
  • Fecha de publicación del evento
    2008-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67307
  • 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
    Differential cell counter - IVD - Product Code GKZ
  • Causa
    Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
  • Acción
    A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 1-800-526-7694.

Device

Device Recall Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager
  • Modelo / Serial
    All Software Versions
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and country of Canada.
  • Descripción del producto
    Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 || A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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