Retiro De Equipo (Recall) de True- Sign hCG reference V9900 (200 tests)

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 ServiBio.

¿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 09 September 2005, the company ServiBio withdrew from the market batches 2005032301 (per 09/2006), 200506903 (per 12/2006) and 2005071001 (per 01/2007) of the in vitro diagnostic medical device called True- Sign hCG reference V9900 (200 tests) following the detection of false negative results. This device is a qualitative first-line test for the detection of hCG in serum and urine, for the biological diagnosis of pregnancy. The company has directly notified the recipients of the incriminated lots by means of the attached message ( 09/09/2005) (15 KB) validated by the Afssaps. This message is completed by a letter Afssaps (09/09/2005) (25 ko) on the modalities to follow for the patients whose hCG screening would have been found negative with the aforementioned lots. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.


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