Events

Retiro De Equipo (Recall) de Columbia Agar ANC + 5% sheep blood

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 BIOMERIEUX.

¿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
    2005-11-15
  • 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-une-partie-d-un-lot-du-dmdiv-gelose-columbia-anc-5-de-sang-de-mouton-biomerieux
  • 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 November 10, 2005, the company bioMérieux removed from the market part of lot 798057301 (per 7/12/2005) produced between 3:43 pm and 7:38 pm of the in vitro diagnostic medical device called Columbia Agar ANC + 5% sheep blood reference 43071. This device is a selective isolation medium for the development of Gram (+) bacteria commonly found in clinical specimens. This measurement results from possible growth inhibitions due to the contamination of the part of the lot with a substance inhibiting certain strains of Staphylococcus and certain strains of Listeria. The production time appears legibly on each petri dish, with the other mentions (type of agar, number of batch, etc ..) .. The company directly warned the recipients of the incriminated batch by means of the attached message (10/11/2005) (14 ko) validated by the Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Columbia Agar ANC + 5% sheep blood
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX