Events

Retiro De Equipo (Recall) de BD ProbeTec CT / AC kit

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 BECTON DICKINSON.

¿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
    2005-07-08
  • 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-kit-bd-probetec-ct-ac-becton-dickinson-diagnostic
  • 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 5, 2005, the Becton Dickinson Diagnostic Company withdrew from the market batches 4345728 (per 30.11.2005) and 4345733 (per 31.12.2005) of the in vitro diagnostic medical device called BD ProbeTec CT / AC kit reference 440474. This decision follows the identification of a risk of an increase in the number of false positive Chlamydia trachomatis results. This device allows the direct qualitative detection of Chlamydia trachomatis DNA from endocervical samples, urethral swabs. in humans and male and female urine samples, as evidence of C. trachomatis infection. The company has directly notified the recipients of the offending lots by means of the enclosed message (08 / 07/2005) (13 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, plant managers health authorities and to the correspondents of reactovigilance for dissemination, where appropriate, to the services concerned.

Device

BD ProbeTec CT / AC kit
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON