Events

Retiro De Equipo (Recall) de Stratus TestPak reagents;Stratus diluents DilPak

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
    2006-04-06
  • 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-des-reactifs-stratus-testpak-et-diluants-stratus-dilpak-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 5, 2006, Dade Behring withdrew from the market 47 batches of Stratus TestPak reagents and Stratus DilPak diluents used on the Stratus CS system, a list of which is detailed in the enclosed mail (05/04/2006) (34 ko) .. In addition, 22 other lots are subject to a reduction in the shelf life to 2 months (see attached letter). These reagents and diluents are used for the quantitative determination of CKMB, troponin I, myoglobin, proBNP, D-dimer and beta hCG on the Stratus CS system. This measure follows the possibility that the aluminum film covering the reagents and diluents may obstruct the sampling tip thus causing insufficient reagent aspiration. The results obtained can then be falsely raised or lowered. The company has directly notified the recipients of the incriminated lots by means of the attached message validated (05/04/2006) (34 KB) by Afssaps. address to laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Stratus TestPak reagents;Stratus diluents DilPak
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM