Events

Retiro De Equipo (Recall) de Flex reagent cartridge CKMB Mass (MMB)

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 DADE BEHRING.

¿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
    2006-04-04
  • 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-cartouche-de-reactif-flex-ckmb-masse-mmb-dade-behring
  • 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 April 3, 2006, the company Dade Behring withdrew from the market batches DE6347 (per 13/12/2006) and CG7003 (per 03/01/2007) of the in vitro diagnostic medical device called Flex reagent cartridge CKMB Mass (MMB) reference RF420. This device is a test to quantitatively measure the creatine kinase MB (CKMB) isoenzyme in human serum and plasma on the Dimension clinical chemistry system. This measure is motivated by quality control results that may have a negative bias of 19% to 45% and checks on patient samples have shown a negative bias of 15% to 25% that can occur with quality controls located in the expected values. The company has directly notified the recipients of the offending batches by means of the attached message (03/04/2006) (17 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Flex reagent cartridge CKMB Mass (MMB)
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM