Events

Retiro De Equipo (Recall) de Reagent B27-FITC / B7-PE

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 BECKMAN COULTER.

¿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
    2005-07-25
  • 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-reactif-b27-fitc-b7-pe-de-beckman-coulter
  • 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 22 July 2005, Beckman Coulter withdrew from the market lot 6 (expiry 01/08/2007) of the in vitro diagnostic medical device called reagent B27-FITC / B7-PE, reference A07739 following the implementation of Evidence of variations in performance from one vial to another may be the source of false positive results. This device is used to demonstrate the expression of HLA-B27 antigen on leukocytes. This highlighting assists in the diagnosis of ankylosing spondylitis. The company Beckman Coulter directly warned the recipients of the offending batch by means of the attached message (22/07/2005) (23 KB) validated by the Afssaps . The competent European authorities concerned are informed directly by the manufacturer. This information is intended for medical biology laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Reagent B27-FITC / B7-PE
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER