Events

Retiro De Equipo (Recall) de Glucose reagent HK

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
    2006-04-13
  • 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-partiel-d-un-lot-du-reactif-glucose-hk-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    On 10/04/06, the company ROCHE DIAGNOSTICS has withdrawn from the market the reagent bottles R2 lot 672 652 of the in vitro diagnostic medical device called glucose reagent HK, reference 11929542, whose numbers are between 12,943 and 13,822 following an abnormally high pH value due to accidental contamination during packaging, making it impossible to obtain a result. This device is used for the in vitro quantitative determination of glucose in human serum, urine and CSF. on Modular analyzers. The company ROCHE DIAGNOSTICS has directly notified the recipients of the offending lot by means of the attached message (10/04/2006) (49 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.

Device

Glucose reagent HK
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics