Events

Retiro De Equipo (Recall) de PhoenixSpec Calibrator 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 BD 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
    2005-12-22
  • 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-bd-phoenixspec-calibrator-kit-bd-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    On 20/12/2005, the company BD Diagnostics has withdrawn lots 5075281 and 5115146 from the in vitro diagnostic medical device called BD PhoenixSpec Calibrator Kit reference 440911. This device is used for the calibration of the BD PhoenixSpec Nephelometer which allows the measurement turbidity of microbial suspensions equivalent to McFarland standards 0.10-4.50. This decision follows the detection of a problem of stability drift of the 0.25 MacFarland calibration tube contained in the aforementioned kits that could lead to a bad calibration of the device BD PhoenixSpec Nephelometer identified by an error message "CAL?" In addition, the manufacturer also reports that the Nephelometer Operator's Manual will be changed to the "CAL?" Error message. The company has directly notified the recipients of the incriminated lots by means of the message attached (20/12/2005) (16 KB) validated by Afssaps. The competent European 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

PhoenixSpec Calibrator Kit
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BD Diagnostics

Manufacturer

BD Diagnostics