Events

Retiro De Equipo (Recall) de Calibrator Dimension® PBNP

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
    2005-11-07
  • 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-calibrateur-dimension-r-pbnp-reference-rc423-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    On 03/11/2005, the company Dade-Behring has withdrawn from the market the batch 5BD009 (01/02/2006) of the in vitro diagnostic medical device called Calibrator Dimension® PBNP reference RC423 .. This measure follows the evidence of a defect in stability leading to a positive bias on the quality control values ​​after recalibration and therefore an overestimation of the patient results. This device is a calibrator for the calibration of the PBNP method, for the quantitative determination of N-terminal proBNP (natriuretic peptide type B) in human plasma on the Dimension® clinical chemistry system .. The company has directly notified the recipients of the offending lot by means of the enclosed message (03/11/2005) ( 13 kb) validated by Afssaps. The relevant European Competent Authorities are informed directly by the competent UK authority, the MHRA. This information is intended for laboratory managers, health facility directors and health-surveillance correspondents for dissemination, as appropriate, to the relevant services. .

Device

Calibrator Dimension® PBNP
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Dade-Behring

Manufacturer

Dade-Behring
  • Source
    LAANSM