Events

Retiro De Equipo (Recall) de Device Recall BD Phoenix PMIC108 Panels

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
    63737
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0570-2013
  • Fecha de inicio del evento
    2012-11-06
  • Fecha de publicación del evento
    2012-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114682
  • 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
    An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
  • Acción
    The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated November 2012 via the telephone and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and discard any remaining packages for replacement and to complete and return the Acknowledgement Receipt Form, whether or not you have any inventory remaining, via fax to: BD Regulatory Compliance at 410-316-4258. BD will issue replacements for the discarded materials. If further assistance is needed regarding replacements please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall BD Phoenix PMIC108 Panels
  • Modelo / Serial
    Lot number 2053373
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
  • Descripción del producto
    BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. || The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
  • 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