Events

Retiro De Equipo (Recall) de Device Recall BD FMC7 FITC

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 and Company, BD Biosciences.

¿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
    73155
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0851-2016
  • Fecha de inicio del evento
    2016-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143258
  • 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,specific,analyte - Product Code MVU
  • Causa
    Becton, dickinson and company (bd) has determined that the fmc7 fitc (asr) has an incorrect expiration date listed on the vial label.
  • Acción
    BD Biosciences sent an Urgent Medical Device Recall letters dated January 2016 via certified mail to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that the remaining stock of the product can be used until 6-30-16. however, if prefer they can discard all remaining stock of the affected lot and BD will replace. The letter request customers complete the Tracking/verification form and returned to BD Biosciences, per the instructions (mail, fax, or email). For questions contact your local BD representative or BD Customer Support at 877-232-8995 (prompt 3,3).

Device

Device Recall BD FMC7 FITC
  • Modelo / Serial
    Model number: 340918: Lot number: 5341918. Incorrect expiry date on label 03/31/2017. correct expiry should be 6/30/16.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.
  • Descripción del producto
    BD FMC7 FITC: Model 430918. || FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. || Product Usage: || Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
  • Manufacturer
    Becton, Dickinson and Company, BD Biosciences

Manufacturer

Becton, Dickinson and Company, BD Biosciences
  • Dirección del fabricante
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA