Events

Retiro De Equipo (Recall) de Device Recall BBL TM LYSINE IRON AGAR

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
    61006
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1108-2012
  • Fecha de inicio del evento
    2012-01-11
  • Fecha de publicación del evento
    2012-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107173
  • 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
    Culture media, antimicrobial susceptibility test - Product Code LKA
  • Causa
    Lysine iron agar may not produce the correct biochemical reactions with quality control organisms over the shelf life of the product.
  • Acción
    BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated January 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining packages. A form was attached for customers to complete and return via fax to: Attention: Regulatory Compliance at 410-316-4258. Contact the BD Technical Services Department at 1-800-638-8663 for questions regarding this recall.

Device

Device Recall BBL TM LYSINE IRON AGAR
  • Modelo / Serial
    Lot number 0204203 Exp. 3/31/14
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TX, VA, and WI, and the countries of Belgium, Canada, Chile, China, Columbia, Costa Rica, Mexico, El Salvador, Ecuador, Japan, Manila, Singapore, Peru, Taiwan, and Venezuela.
  • Descripción del producto
    BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on their ability to decarboxylate or dominate lysine and to form hydrogen sulfide. Becton, Dickinson and Company, Sparks, MD 21152 USA 38800 Le Pont de Claix, France. || Lysine Iron Agar was developed for the use for differentiation of enteric organisms, in particular Salmonella species due to its ability to decarboxylate or deaminate lysine and form hydrogen sulfide.
  • 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