Events

Retiro De Equipo (Recall) de AxSYM DMDIV and IMx / Folates

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 DIAGNOSTIC.

¿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
    2004-01-08
  • 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-de-lots-de-dmdiv-axsym-et-imx-folates-par-abbott-diagnostic
  • 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
    Abbott Diagnostic withdraws from the market the following batches of in vitro diagnostic medical devices called:. AxSYM / Folate. Specific thinner - reference 3C81-5. lot 05920M200 (per.21.04.04). Erythrocyte Protein Diluent - reference 3C81-6. lot 06783M100 (per.16.02.04). Medium Control - reference 3C81-1. lot 01552M100 (per.17.01.04). IMx / Folate. Medium Control - reference 2220-1. lot 06320M200 (per.10.04.04). Calibrator Mode 1 - reference 2220-4. lot 06371M200 (per.21.05.04). Specific thinner - reference 2220-5. lot 03234M300 (per.11.04.04). Controls Low and High Folate - reference 9C13-1. lots 95523M200 (per.06.03.04) and 08899M100 (per.23.08.04); due to a lack of stability of human serum albumin in their composition; this defect may lead to lower than standard test results and patient results lower than expected only for diluted samples. These devices are intended for the determination of folates in serum, plasma and human erythrocytes on the AxSYM and IMx PLCs. The results of this assay should be used in conjunction with other available data such as the results of other biological analyzes and clinical data.

Device

AxSYM DMDIV and IMx / Folates
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    ABBOTT DIAGNOSTIC

Manufacturer

ABBOTT DIAGNOSTIC
  • 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