Events

Retiro De Equipo (Recall) de ACCELERATOR Automated Processing 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 Abbott Laboratories, 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
    50488
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2221-2009
  • Fecha de inicio del evento
    2008-10-27
  • Fecha de publicación del evento
    2009-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75490
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    When an architect c16000 system is connected to an accelerator aps system, the software on the accelerator aps system may not generate an error warning when a sample presentation/sample queue error occurs, which could result in contamination of subsequent samples.
  • Acción
    Abbott Laboratories notified Customers of the affected device via a "Product Correction" letter dated October 27, 2008. Consignees provided with a temporary work around until a service representative upgrades the system software. For further information, contact your local Abbott Laboratories, Inc. service representative.

Device

ACCELERATOR Automated Processing System
  • Modelo / Serial
    Serial Numbers: ABT 042, ABT 055, ABT 037, ABT 016, ABT 041, ABT 046, ABT 035, ABT 040, ABT 039, ABT 033, ABT 028, ABT 011, ABT 006 and ABT 007.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.
  • Descripción del producto
    ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Dirección del fabricante
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038-4313
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • 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
    USFDA