Retiro De Equipo (Recall) de Plasma free of factor VIII coagulation

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
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  • 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 July 13, 2005, the company Dade-Behring removed from the market batches 503846A, 503850C and 503853A of the in vitro diagnostic medical device called Plasma free of factor VIII coagulation reference OTXW. In addition, batches 503847D, 503849D, 503849E, 503856B, 503856C, 503857A, 503858A, 503848A, 503859B, 503860D and 536501 of this same device are the subject of recommendations for use. This device is used when assaying coagulation factor VIII activity in human plasma by coagulometric methods. These decisions stem from the possibility of falsely elevated patient outcomes that may lead to misdiagnosis of the severity of hemophilia A or the inability to accurately track substitution therapy. The company has directly notified recipients incriminated lots by means of the attached message validated (13/07/2005) (104 ko) by the Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for those responsible for laboratory, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.


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