Events

Retiro De Equipo (Recall) de MRSA Agar

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
    2005-07-20
  • 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-du-dmdiv-gelose-mrsa-id-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    On July 18, 2005, the company bioMérieux has withdrawn batches 795418401, 795204401, 794959301, 794783401, 794530501 from the in vitro diagnostic medical device called MRSA Agar ID reference 43451. This decision follows the possible decrease of the activity of the selective mixture used in the composition of this product. This decreased activity results in methicillin-sensitive Staphylococcus aureus strains exhibiting the growth and staining characteristics of methicillin-resistant Staphylococcus aureus. This device is a chromogenic culture medium for the detection and identification of methicillin-resistant Staphylococcus aureus (MRSA) from human specimens. The company has directly notified the recipients of the offending lots by means of the message. hereby validated (18/07/2005) (148 ko) 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

MRSA Agar
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX