Events

Retiro De Equipo (Recall) de BD GeneOhm Cdiff Assay

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Becton Dickinson & Co..

¿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
  • ID del evento
    66933
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0790-2014
  • Fecha de inicio del evento
    2013-10-11
  • Fecha de publicación del evento
    2014-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124243
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Reagents, clostridium difficile toxin - Product Code LLH
  • Causa
    An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for clostridium difficile in patient samples.
  • Acción
    Becton Dickinson sent an Urgent Product Recall Letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They were advised that a portion of the BD GeneOhm Cdiff assay test kits from one lot, 08T13108, may contain incorrect bags of sample buffer tube. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was discarded. Please fax to 410-316-4258.

Device

BD GeneOhm Cdiff Assay
  • Modelo / Serial
    Lot 08T13108 Exp Dec 24 2013
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
  • Descripción del producto
    BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** || The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Dirección del fabricante
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA