Events

Retiro De Equipo (Recall) de FusionQuant® Kit m-bcr

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 IPSOGEN SAS.

¿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
    2005-11-30
  • 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-fusionquant-r-kit-m-bcr-ipsogen-sas
  • 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 29/11/2005, the company IPSOGEN SAS withdrew the lot 05-04-01 (per 03/2006) from the in vitro diagnostic medical device called FusionQuant® Kit m-bcr reference FQPP-09-CE. This device is used for real-time Quantitative PCR analysis of the m-bcr Transcript in bone marrow or peripheral blood samples of patients with Acute Lymphocytic Leukemia or Ph-positive Chronic Myeloid Leukemia. m-bcr fusion has already been diagnosed. This measure follows the discovery of a defect in the stability of this batch resulting in the production of a standard ABL curve (for the control gene). ABL) having an upper slope and intercept in absolute value than the reference values, this invalidating the series of assays. The company has directly notified the recipients of the offending batch by means of the attached message (29/11/2005) (25 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of establishments health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

FusionQuant® Kit m-bcr
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    IPSOGEN SAS

Manufacturer

IPSOGEN SAS
  • Source
    LAANSM