Events

Retiro De Equipo (Recall) de Device Recall BD Phoenix" Panel NMIC/ID123, Catalog 448723,

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 & Co..

¿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
    58066
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1847-2011
  • Fecha de inicio del evento
    2011-02-28
  • Fecha de publicación del evento
    2011-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98199
  • 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
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    In vitro diagnostic test kit is defective and may cause false positive or false negative results.
  • Acción
    BD Diagnostics Systems sent an Urgent Product Recall letter dated February 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinsue use of the affected product and discard any remaining packages. BD would issue replacements for the discarded material. Customers were instructed to complete the attached form whether or not they had any inventory remaining so that the firm may acknowledge receipt of this notification. Complete and fax the form to BD Regulatory Compliance to 410-316-4258. For further assistance contact BD Customer Service at 1-800-675-0908. For other inquiries, contact BD Technical Services at 1-800-638-8663.

Device

Device Recall BD Phoenix" Panel NMIC/ID123, Catalog 448723,
  • Modelo / Serial
    Lot 0223498 exp 8/31/2011
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ, CA, FL, GA, MA, MD, NC, NY, PA, TX, WA, WI, and WY and the countries of The product was distributed to medical facilities nationwide and to foreign consignees in Argentina, Brazil, Chile, and Mexico.
  • Descripción del producto
    BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663*** || The BD Phoenix¿ Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The Phoenix system provides results for most aerobic and facultative anaerobic Gram negative bacteria of human origin with the use of the NMIC/ID-123 panel type.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Dirección del fabricante
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA