Events

Retiro De Equipo (Recall) de Test Pack Plus hCG Combo

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 Inverness Medical France.

¿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
    2005-08-12
  • 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-test-pack-plus-hcg-combo-inverness-medical-france
  • 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 August 10, 2005, Inverness Medical France withdrew from the market lot 17597M200 of the in vitro diagnostic medical device called Test Pack Plus hCG Combo reference 3A6016FR following the possibility of obtaining false positive results .. This device is a test immunoassay used for the early detection of pregnancy by qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. In the case of a positive result, this test is confirmed by a quantitative determination in the serum. The company has directly notified the recipients of the offending lot by means of the attached message (10/08/2005) (26 KB) validated by Afssaps. The relevant European authorities concerned are informed by the manufacturer .. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Test Pack Plus hCG Combo

Manufacturer

Inverness Medical France
  • Source
    LAANSM