Events

Retiro De Equipo (Recall) de Vitros Immunodiagnostic Products / IgM anti-VHA standard

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
    2000-05-23
  • 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-de-lots-de-reactif-denomme-vitros-immunodiagnostic-products-etalon-igm-anti-vha
  • 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
    Lot 60 of the reagent called Vitros Immunodiagnostic Products / IgM anti-VHA standard (reference 1372101) from the company ORTHO CLINICAL DIAGNOSTICS is withdrawn from the market due to a risk of lowering the signal that may cause a rise in the values ​​of the controls beyond the specifications and elevation of values ​​of patient samples. As a result, from the date of expiration of the calibration curve that has been validated by control values ​​in accordance with those expected after use of the standard control protocol, lot 60 of the reagent called Vitros Immunodiagnostic Products / cartridge IgM anti-HAV reagent (reference 8450124), mandatory for use with the former, is also withdrawn from the market.

Device

Vitros Immunodiagnostic Products / IgM anti-VHA standard

Manufacturer

ORTHO CLINICAL DIAGNOSTICS