Events

Retiro De Equipo (Recall) de E. coli/P. aeruginosa PNA FISH

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 Advandx Inc.

¿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
    63199
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0116-2013
  • Fecha de inicio del evento
    2012-09-14
  • Fecha de publicación del evento
    2012-10-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112961
  • 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
    Some strains of pseudomonas putida cross-react with the p. aeruginosa pna probe used in e. coli/p. aeruginosa pna fish (kt007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal.
  • Acción
    AdvanDx notified customers on September 14, 2012 by email along with a PDF file of the new package insert to each contact followed by written notification and a paper copy of the new package insert via FedEx courier. The notification described the product, problem and actions to be taken. The customers were instructed to destroy the package insert in any existing inventory of the kit and replace it with the enclosed package insert. "Note: All shipments of E. coli/P.aeruginosa PNA FISH as of September 14, 2012, will contain this new package insert." The customers were also instructed to complete and return the Acknowledgement of Receipt form to AdvanDX: Regulatory Affairs; 400 TradeCenter, Suite 6990, Woburn, MA 01801-7476; Fax to: +1 (781) 376-0111; bsc@advandx.com. If you have any questions or requests for further information, please contact AdvanDx Technical Support: US (Toll-Free): 1-866-376-0009, techsupport@advandx.com.

Device

E. coli/P. aeruginosa PNA FISH
  • Modelo / Serial
    Lot Numbers: 01812A-US, 03412A-US and 00512A-EU  Exp Date: 12-2013
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.
  • Descripción del producto
    AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa || Catalog Number : KT007 || Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
  • Manufacturer
    Advandx Inc

Manufacturer

Advandx Inc
  • Dirección del fabricante
    Advandx Inc, 400 Tradecenter, Ste 6990, Woburn MA 01801
  • Empresa matriz del fabricante (2017)
    Advandx, Inc.
  • Source
    USFDA