Events

Retiro De Equipo (Recall) de ID-DiaCell I-II-III

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 Diamed.

¿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
    2005-11-03
  • 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-du-dmdiv-id-diacell-i-ii-iii-diamed
  • 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 October 31, 2005, the company DIAMED removed from the market the lot 45184.47.1 (per 14/11/2005) of the reference 004310 and the lot 45404.47.1 (per 14/11/2005) of the reference 004304 of the in vitro diagnostic medical device referred to as ID-DiaCell I-II-III. These are test red cells for ID-Micro Typing System, for Irregular Antibody Research (RAI). This measure follows an isolated problem encountered with an anti-E antibody, probably natural, of low titer, not detected in cardiac indirect Coombs technique with gelatin n 2, phenotype R2R2 (D + C-E + c + e-) of these two screening panels. To date, there is no evidence to suggest that the red cell 2 has a major problem of expression of the E antigen (control and confirmation of the Rhesus / Kell phenotype, human anti-E antibody patients). Investigations are in progress at the National Reference Center for Blood Groups (CNRGS). The company has directly notified the recipients of the incriminated lots by means of the attached message (31/10/2005) (12 KB) validated by the Afssaps .. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

ID-DiaCell I-II-III
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Diamed

Manufacturer

Diamed
  • Source
    LAANSM