Events

Retiro De Equipo (Recall) de Device Recall BD Bioscience Trucount Absolute Counting Tubes

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
    73748
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1570-2016
  • Fecha de inicio del evento
    2016-03-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144863
  • 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
    One lot of lot of bd trucount tubes may contain tubes from another lot. there is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.
  • Acción
    BD Biosciences sent an Urgent Product Recall letter dated March 2016 to all affected customers on March 31, 2016 by Certified Mail, e-mail and direct delivery by Sales Associates. Letters instructed that any remaining inventory of the affected lot be discarded and that date files obtained using reagents from the affected lot be reviewed for the possibility of incorrect data. Customers with questions were instructed to contact BD Customer Support at 877-232-8995 (prompt3, 3) in the united State. For customers outside the US, customers should contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6080.

Device

Device Recall BD Bioscience Trucount Absolute Counting Tubes
  • Modelo / Serial
    Model: 340334; Manufacaturing lot: 534964
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India.
  • Descripción del producto
    BD Trucount Absolute Counting Tubes: || Model number: 340334 || IVD; || BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
  • 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