Events

Retiro De Equipo (Recall) de Device Recall UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems

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
    55164
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2771-2011
  • Fecha de inicio del evento
    2009-05-07
  • Fecha de publicación del evento
    2011-07-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90200
  • 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
    Antibody Radioassay - Product Code LIG
  • Causa
    The recall was initiated after beckman coulter confirmed reports of inaccurate access intrinsic factor ab test results displayed on, or printed from, the unicel dxl portion of an integrated workstation listed above. the problem is limited to numerical intrinsic factor ab results produced on integrated systems running unicel dxl system software version 4.0, 4.1, or 4.2. the dxc portion of your inte.
  • Acción
    Beckman Coulter, Inc. sent out an "Urgent: Product Corrective Action" letter dated May 19, 2009 to all affected customers. The letter explained the reason for recall and provided recommendations including: -System software currently under development will correct this problem, and will be made available soon. Until then, please refer to UniCel DxC reports, user interface information, and LIS transmissions, which contain accurate Access Intrinsic Factor Ab test results. -Refer to the UniCel DxC system documentation for information on displaying and printing results from the DxC portion of an integrated workstation, or from your laboratory information system (LIS) -Past results for these assays only need to be reviewed if they were reported from the Dxl portion of an integrated workstation -Complete and return the enclosed response form For additional information please contact the Customer Technical Support at 1-800-854-3633, or your local Beckman Coulter representative.

Device

Device Recall UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: (USA) Nationwide including KY; and the country of Canada.
  • Descripción del producto
    UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems || The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA