Events

Retiro De Equipo (Recall) de Disposable Tips 1000 μl with filter

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 TECAN.

¿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
    2005-11-25
  • 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-disposable-tips-1000-l-with-filter-tecan
  • 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 17/11/2005, TECAN informed Afssaps of the withdrawal of lots U122098L-1325, U122098L-3225 and U122098L-2325 from the in vitro diagnostic medical device called Disposable Tips 1000 μl with filter reference 612 513.1. These are tips for Tecan Genesis .. reagents / sample dispensers. This measurement follows the discovery of a tip defect (presence of two filters instead of one) that may cause reactive sampling problems. / sample resulting in false negative or positive results. The company notified the users directly on 17/11/2005, by means of the attached message (25/11/2005) (16 KB). users, no tip of the aforementioned lots was used in the context of a diagnosis. Therefore, this withdrawal does not require patient-specific measures. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and health and safety correspondents. dissemination, where appropriate, to the services concerned.

Device

Disposable Tips 1000 μl with filter
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    TECAN

Manufacturer

TECAN
  • Source
    LAANSM