Events

Retiro De Equipo (Recall) de Device Recall ADVIA 2120 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 Bayer Healthcare, LLC (Diagnostics Division).

¿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
    35893
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1376-06
  • Fecha de inicio del evento
    2006-03-16
  • Fecha de publicación del evento
    2006-08-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47098
  • 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
    Blood Cell and Differential Cell Counter - Product Code GKL
  • Causa
    The advia 2120 has reported ; highly intermittent low results on all primary results: white blood cells (wbc), red blood cells (rbc), hemoglobin (hgb) and platelets (plt) and an abnormal baso cytogram.
  • Acción
    Bayer HealthCare LLC issued Support Bulletins to all affected Bayer HealthCare LLC Branches on 3/16/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Bayer also issued Customer Bulletins to the Branches both in the United States and elsewhere for communication with the affected customers.

Device

Device Recall ADVIA 2120 systems
  • Modelo / Serial
    ADVIA 2120 Part No. 067-A012-01 (without Autosampler) and Part No. 067-A011-02 (with Autosampler); all ADVIA 2120 systems using Version 5 system software including Version 5.0.6 (Part No. 067-S045-06, English version), Version 5.1.1 (Part No. 067-S058-01, English version), and Version 5.2.7 (Part No. 067-S045-15, English version).
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution-Domestic consignees consist of hospitals and clinical laboratories. Foreign countries (units): Canada (1), China (4), Singapore (1), Malaysia (2), Thailand (1), Taiwan (1), Vietnam (1), Australia (3), Korea (25), Japan (25), Israel (4), Saudi Arabia (4), Russia (1), Turkey (1), United Arab Emirates (1), South Africa (2), United Kingdom (31), Germany (1), Poland (9), Norway (1), Spain (48), Finland (7), Denmark (4), Portugal (14), Italy (5), Netherlands (3), France (46), Ireland (4), India (7), Austria (1).
  • Descripción del producto
    ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)

Manufacturer

Bayer Healthcare, LLC (Diagnostics Division)
  • Dirección del fabricante
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591-5097
  • Source
    USFDA