Events

Retiro De Equipo (Recall) de Device Recall BD FACS 7color Setup Beads

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
    62494
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2397-2012
  • Fecha de inicio del evento
    2012-06-29
  • Fecha de publicación del evento
    2012-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110758
  • 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
    Incorrect version of the cd was included with bd facs 7 color setup beads.
  • Acción
    BD Biosciences sent a Important Product Recall Information letter beginning July 3, 2012, to all affected consignees via Fed Express. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed that the CD enclosed in their recent purchase of BD FACS 7-Color Setup Beads, lot number 33412, contain CD version 2.0 instead of the newer version 3.0. The letter goes on to explain the the potential risk and include a table of listed range values to determine if a potential false pass or false fail for the listed detectors has occurred. Customers are asked to check the CD with the kit to ensure that it is version 3.0 (the kit lot number ID is on the CD label). If it is not the correct version, discard version 2.0 and do not use it with this bead kit. Call BAD customers service for a replacement. If the 2.0 kit was already uses, letters request that clinicians inspect the FITC and APC-CY7 stains in the plots of the laboratory reports for the clinical applications in BD FACSCanto clinical software for compromised resolution between negative and dim populations. The verification form/effectiveness check should be completed and returned as requested. Questions or concerns may be directed to BD Customer Support at 1-855-236-2772.

Device

Device Recall BD FACS 7color Setup Beads
  • Modelo / Serial
    Catalog number: 335775; Lot number 33412.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
  • Descripción del producto
    BD FACS 7-color Setup beads || BD Biosciences, San Jose, CA 95131. || BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
  • 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