Events

Retiro De Equipo (Recall) de Device Recall Abbott AxSYM Cancer Assay Disk Version 5.0

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.

¿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
    51275
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2222-2009
  • Fecha de inicio del evento
    2009-02-20
  • Fecha de publicación del evento
    2009-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79570
  • 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
    Kit, test,alpha-fetoprotein for testicular cancer - Product Code LOJ
  • Causa
    The axsym cancer assay disk (ln 3d50-05 version 5.0) contains an axsym afp assay file where the low concentration flag for the afp 1:101 automated dilution protocol the instrument to report results between 0 ng/ml and 0.4 ng/ml (40.4 ng/ml accounting for the 1:101 dilution). the sensitivity of the assay is 0.4 ng/ml.
  • Acción
    Abbott sent "Product Correction Immediate Action Required" letters dated February 2, 2009 to all AxSYM AFP customers. Customers were requested to install the updated version of the AxSYM AFP assay using version 6.0 of the AxSYM Cancer Assay Disk provided with the letter and to retain a copy of this communication for their records. Any questions regarding the letter were directed to Customer Service at 1-877-4ABBOTT.

Device

Device Recall Abbott AxSYM Cancer Assay Disk Version 5.0
  • Modelo / Serial
    List Number 3D50-05, version 5.0
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (including Puerto Rico), Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Curacao (Neth Ant), Dominican Republic, Germany, Guatemala, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Trinidad and Tobago, Turks and Caicos and Venezuela.
  • Descripción del producto
    Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. || AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Dirección del fabricante
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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