Retiro De Equipo (Recall) de Device Recall GCX Mountable DownloaderRecharger;

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 Abbott Point of Care 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Causa
    Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
  • Acción
    Abbott Point of Care, Inc. sent Urgent Recall Notices, dated August 20, 2010, by Federal Express to two Clarion Health locations. The letter identified the product, the issue, and the actions to be taken by the firm and the customers. 1) An Abbott Point of Care representative will contact the customers to plan the replacement of affected product at their facility. 2) Replacement will occur in batches of approximately 50 units at a time. 3) Abbott will provide personnel to perform the replacements to help expedite the replacement. 4) The customer is required to acknowledge that all units have been replaced by signing the form provided with the Urgent Recall Notice.. If you have any questions regarding this information please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.


  • Modelo / Serial
    List number: 06F23-57/514005, part number 016060-01.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution - USA, including the state of Indiana
  • Descripción del producto
    GCX Mountable Downloader-Recharger; || (accessory to the i-STAT Portable Clinical Analyzer (model 300). || The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems.
  • Manufacturer


  • Dirección del fabricante
    Abbott Point of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source