Events

Retiro De Equipo (Recall) de Device Recall BD FACS Sample Prep Assistant III (BD SPA III)

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 BD Biosciences, Systems & Reagents.

¿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
    55748
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0316-2011
  • Fecha de inicio del evento
    2010-02-19
  • Fecha de publicación del evento
    2010-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91715
  • 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
    Counter, differential cell - Product Code GKZ
  • Causa
    Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. having a piece of the lid partially or fully clogging the probe during piercing a hole in the lid of tube may cause inaccurate sample dispense, resulting in incorrect test results. the piece of the lid clogging the probe can be in the processed sample tube. it has the.
  • Acción
    BD Biosciences sent an "Important Product Information" letter dated February 2010 and an "URGENT: Follow-Up to Letter Dated February 2010" letter dated July 2010 to customers identifying the affected device and actions to be taken: Customers were instructed to stop use of the SPA probes and to contact BD for replacement of the affected probes and assistance in the event of probe clogging. BD has arranged replacement of affected probes. BD's followup communication detailed the potenial hazards and reiterated remedial actions in the event of error messages from FACS flow cytometers. Customers with questions about the performance of theirr SPA instrument or the content of the letters may contact BD Customer Support at 1.877.232.8995, prompt 2.

Device

Device Recall BD FACS Sample Prep Assistant III (BD SPA III)
  • Modelo / Serial
    Model/Catalog No. 647205. Manufacturing Lot/Serial # X0039; Sample Probe Catalog Numbers: 333494, 333485, 339118, 647768, and 647769/Lot Nos. 92035 and 92036
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium.
  • Descripción del producto
    BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. || The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.
  • Manufacturer
    BD Biosciences, Systems & Reagents

Manufacturer

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