Events

Retiro De Equipo (Recall) de AxSYM® Anti-TPO

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por ABBOTT.

¿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
  • Fecha
    2005-07-07
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-du-dmdiv-axsym-r-anti-tpo-abbott-france
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Notas adicionales en la data
  • Acción
    On 30 June 2005, ABBOTT France withdrew from the market lot 22827HN00 (per 12/09/2005) of the in vitro diagnostic medical device known as AxSYM® Anti-TPO reference 5F57-20. This decision follows the identification of an error during the final manufacturing phase of this lot. Indeed, the AxSYM Anti-TPO assay diluent (reagent 3) has been erroneously replaced by another solution in some of the packs of this lot. This device is used for the quantitative measurement of IgG autoantibodies directed against thyroperoxidase (anti-TPO) in human serum or plasma. It is an aid for the diagnosis of thyroid diseases .. The company has directly notified the recipients of the offending lot by means of the attached message (30/06/2005) (88 KB) validated by Afssaps .. This information s address to laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

AxSYM® Anti-TPO
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    ABBOTT

Manufacturer

ABBOTT
  • 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
    LAANSM