Events

Retiro De Equipo (Recall) de VITROS Signal Reagent

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 Ortho-Clinical 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
    2006-04-05
  • 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-reactif-signal-vitros-ortho-clinical-diagnostics-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 April 3, 2006, Ortho-Clinical Diagnostics France withdrew from the market lot 8350 (05/06/2006 expiry) of the in vitro diagnostic medical device called Signal Reagent VITROS reference CAT 107 2693 following the receipt of claims relating to biases observed on the results when using this lot of reagent. This device is used to generate the luminescence signal in all Immunoassay tests on VITROS ECi / ECiQ systems. In addition, the company informs all users of VITROS ECi / ECiQ systems of the need to follow a reinforced quality control procedure for each pack of all lots of VITROS Signal Reagent used, by means of the enclosed message (03/04 / 2006) (275 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned. Alert of 17 July 2006 - update

Device

VITROS Signal Reagent

Manufacturer

Ortho-Clinical Diagnostics