Events

Retiro De Equipo (Recall) de UniCel DxH 800 Coulter Cellular Analysis System

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
    58282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2114-2011
  • Fecha de inicio del evento
    2010-10-20
  • Fecha de publicación del evento
    2011-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98884
  • 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
    Counter, differential cell - Product Code GKZ
  • Causa
    For panels containing cbc: the rbc and hct are improperly corrected and not flagged when there is a wbc pump failure and the wbc ~ 140x103/ul. for body fluid panels: the rbc is improperly corrected and not flagged when there is a wbc pump failure. impact: erroneous rbc and/or hct could affect the interpretation and management of patients at risk with various types of anemias.
  • Acción
    The recall communication was initiated on 10/20/2010, with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with PCA Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter informs the customers about the problems identified and provides an action/resolution to this issue. When a WBC Pump Failure occurs, the WBC or TNC results will be flagged with 'R' and the WBC Pump Failure System message. The RBC and/or HCT results associated with these affected analyses also require review. This will be corrected in a future version of software. Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation. Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative.

Device

UniCel DxH 800 Coulter Cellular Analysis System
  • Modelo / Serial
    All serial numbers, SW version 1.1.3.0
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including:Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 || The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA