Retiro De Equipo (Recall) de iSTAT Analyzer FUSO Analyzer 300F

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 2
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Causa
    I-stat analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
  • Acción
    Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed. Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action. Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011.


  • Modelo / Serial
    Product number: 310003, all lots
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Finland, Georgian Republic, Greece, Honduras, France, Germany, Italy, Netherlands, New Zealand, Hong Kong, India, Ireland, Israel, Japan, Kingdom of Saudi Arabia, Korea, Kuwait, Mauritius, Mexico, Nigeria, Norway, Panama, Paraguay, Peoples Republic of China, Peru, Poland, Portugal, Qatar, Russia, Singapore, South Africa, Spain, Sweden, UK, Sultanate of Oman, Switzerland, Taiwan, R.O.C., Thailand, Turkey, UAE, Uruguay, and Yemen.
  • Descripción del producto
    FUSO Analyzer 300F || Abbott Point of Care, Princeton, NJ 08540 || Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
  • 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