Events

Retiro De Equipo (Recall) de AMPLICOR HPV Amplification

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 Roche Diagnostics.

¿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
    2005-04-11
  • 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-kit-amplicor-hpv-amplification-roche-diagnostics
  • 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 6, 2005, the company ROCHE Diagnostics withdrew from the market lot F09579 of the medical device for in vitro diagnostic called Kit AMPLICOR HPV Amplification reference 3610799190 following. the possibility of obtaining more frequent ß-globin Optical Density results for the positive control, leading to the invalidation of the series. the theoretical possibility that a sample with a very low HPV titre may give a negative result even though the series has been validated by the positive control. This device is used for the detection of high-risk human papillomavirus (HPV) DNA genotypes in clinical specimens (cervical cells taken in liquid medium). The company has directly notified the recipients of the offending lot by means of the message. attached (06/04/2005) (78 ko) validated by the Afssaps .. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

AMPLICOR HPV Amplification
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics