Events

Retiro De Equipo (Recall) de BACTEC" FX System Software

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
    58873
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2626-2011
  • Fecha de inicio del evento
    2010-08-10
  • Fecha de publicación del evento
    2011-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100453
  • 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, blood culturing - Product Code MDB
  • Causa
    In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.
  • Acción
    BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated August 2010 to all affected customers. The letter describes the product, problem and action to be taken. The letter described the type of error messages the customers may experience. All affected units will be scheduled for on site software update as well as a disk drive replacement. A BD field service engineer will contact the customers to schedule the on site visit. Customers experiencing issues prior to the scheduled visit or have questions should contact the BD Diagnostics Service Department at 800-638-8663.

Device

BACTEC" FX System Software
  • Modelo / Serial
    Catalog # 441398-Serial numbers:V100E, V101F, V200B, V210A, V220B, V221A, and V230B  Catalog # 441750-Serial number: V100A
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.
  • Descripción del producto
    BACTEC" FX System Software, catalog #441398 and #441750 || The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
  • 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