Events

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

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
    51208
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1620-2011
  • Fecha de inicio del evento
    2009-01-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79200
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Causa
    To prevent a needle stick while replacing the probe, the firm has initiated a field correction, and issued an improved users guide procedure (user bulletin, part number 645050).
  • Acción
    The firm, BD Biosciences, sent an information letter dated December 2008 with an enclosed New Probe Replacement Service/User Bulletin, to the customers. The letter described the product, problem and action to be taken. The customers were instructed to review the attached User Bulletin (Part Number 645050); ensure that their laboratory follows the updated procedure for removing and replacing probe; place the User Bulletin in their BD FACS SPA or SPA II User's Guide; always follow the instructions in User Bulletin to properly remove and replace probe, and complete and return the Effectivity Form via fax to 408-577-1409. Should you have any comments or questions, please contact BD Biosciences at 1-877-232-8995 in the US. Outside the US, contact your regional BD office or field service engineer for assistance.

Device

Device Recall BD FACS Sample Prep Assistant (SPA and SPA II)
  • Modelo / Serial
    Lot Number: T0040
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including: Hong Kong, Australia, Belgium, Canada, El Salvador, Hong Kong, Japan, and Mexico.
  • Descripción del producto
    BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, || Model Number: 334080, || Product is manufactured and distributed by BD Biosciences, San Jose, CA || The intended use for the BD FACS Sample Prep Assistant (SPA and SPA II) is to prepare human whole blood for flow cytometry.
  • 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