Retiro De Equipo (Recall) de ImmunoComb II HCV IgG

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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 February 17, 2006, INVERNESS MEDICAL France withdrew lot 051102 from the in vitro diagnostic medical device called ImmunoComb II HCV IgG reference 60455002FR. This device is a rapid test for IgG antibodies against hepatitis C virus in human serum and plasma. This follows a demonstration of a drop in reagent stability that appears to affect the overall sensitivity of the kit with a risk of causing false negative results. The company has directly notified the recipients of the offending lot by means of the attached message (17/02/2006) (22 KB) validated by Afssaps. This message is completed by a letter Afssaps (17/02/2006) (18 ko) on the need to carry out the retest of all sera made negative, with this lot of reagent, using another reagent CE marked. The competent European authorities concerned are informed by Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned. Mail Inverness Medical France (17/02/2006) (22 KB Courrier Afssaps (17/02/2006) (18 KB)



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