Retiro De Equipo (Recall) de Device Recall BBL Crystal Enteric/Nonfermentor (E/NF) Identification System

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Kit, identification, enterobacteriaceae - Product Code JSS
  • Causa
    A portion of the bbl crystal enteric/nonfermentor (e/nf) identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. a portion of these kits contain crystal inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. the expiration date printed on the individual crystal inoculum fluid bottles is correct.
  • Acción
    BD Diagnostic sent an Urgent Product Recall letter dated May 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Please discard any outer kit boxes that are labeled with the incorrect expiration date. All components of the kit will perform as expected with the expiration dates on each component. Our records indicate you may have been shipped a portion of the above-referenced product between August 23, 2013, and the present day. Please complete the attached form whether or not you have any inventory remaining so that we may acknowledge your receipt of this notification. It is not necessary to contact BD by telephone. Simply complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258. If further assistance is needed, please contact the BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact the BD Technical Services Department at 1-800-638-8663. Please accept our apology for any inconvenience this may cause. BD is committed to providing you with the highest quality products. Thank you for your continued support. : -" / 06 . ;/ i )!.U fJJ aLA. Thierry Guilltrt Gail Claiborne Marketing / Regulatory Compliance


  • Modelo / Serial
    Lot. Number - 3224281 / Exp. Date - 2014/06/09 ,  Lot. Number - 3290379 / Exp. Date - 2014/07/24, Lot. Number - 3224281 / Exp. Date - 2014/06/09
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
  • Descripción del producto
    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
  • Manufacturer


  • Dirección del fabricante
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Empresa matriz del fabricante (2017)
  • Source