Events

Retiro De Equipo (Recall) de Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731,

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
    55867
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2025-2010
  • Fecha de inicio del evento
    2010-05-19
  • Fecha de publicación del evento
    2010-07-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92092
  • 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
    Antigens, febrile, slide and tube, all groups, salmonella spp - Product Code GNC
  • Causa
    In vitro diagnostic reagent to aid in the diagnosis of salmonellosis may exhibit decreased or no reactivity. if proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. if control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.
  • Acción
    The recalling firm notified customers by fax and e-mail on 05/19/10. The notification advised that the referenced lot number of Salmonella 0 Group A Antigen may exhibit decreased or no reactivity when testing the patient's serum directly for homologous antibodies by either a slide or tube agglutination test to aid in the diagnosis of Salmonellosis. The recalling firm also advised that they would issue replacements for the referenced lot number under Catalog number 240731, which would not be available until approximately July 15, 2010. Consignees were requested to return enclosed response form. Customers with questions about replacements should contact BD customer service at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731,
  • Modelo / Serial
    Lot 9126057, Exp May 04, 2012
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was sold to distributors nationwide and to affiliates in Belgium and Korea.
  • Descripción del producto
    Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson and Company, Sparks, MD 21152***
  • 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