Events

Retiro De Equipo (Recall) de Device Recall BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack

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
    64444
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1215-2013
  • Fecha de inicio del evento
    2013-02-08
  • Fecha de publicación del evento
    2013-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116151
  • 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, for isolation of pathogenic neisseria - Product Code JTY
  • Causa
    Increased levels of false positives in bd probe tech neisseria gonorrhoeae q amplified dna assay kits.
  • Acción
    BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter via UPS overnight delivery on February 8, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to verify that these kits have been consumed, returned or destroyed by completing the enclosed form. The firm will issue a no charge replacement for customers' product. Any product remaining in customers' inventory should be discarded or destroyed per their facility procedures. Complete the attached form regardless if any inventory remains, so that the firm may acknowledge customers' receipt of this notification. It is not necessary to contact BD by telephone to receive replacements. Complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 OR E-mail to RegulatoryComplianceFax@BD.com. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908.

Device

Device Recall BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack
  • Modelo / Serial
    Lot No./Exp. Date: 2237214 / 2013-10-31.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of CA, FL, GA, NJ, and TX.
  • Descripción del producto
    BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. || Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
  • 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