Retiro De Equipo (Recall) de Device Recall E.faecalis/OE 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • 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
    fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis - Product Code OAH
  • Causa
    Some strains of streptococus anginosus cross-reach with e. faecalis/oe pna fish to produce a false positive green signal.
  • Acción
    The firm, AdvanDx, sent a letter dated June 8, 2010, and email notification on June 11, 2010, to all customers. The letter described the product, problem and action to be taken by customers. AdvanDx notified the customers that there was a change to the package insert under "limitations" to include the statement "some strains of Streptococcus anginosus produce a false green positive fluorescence due to sequence similarities and enclosed a package insert for all E. facealis/OE PNA FISH (KT003) kits. The customers were instructed to replace the Package Insert (revision B) included with any kits in their inventory with the enclosed Package Insert (revision C). Note: All shipments of E. faecalis/OE PNA FISH, as of June 14, 2010, will contain this new package insert. If you have any questions or requests for further information, please contact AdvanDx Technical Support at US (Toll Free): 1-800-376-0009 or email


  • Modelo / Serial
    Catalog number KT003
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
  • Descripción del producto
    E.faecalis/OE PNA FISH || Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media
  • Manufacturer


  • Dirección del fabricante
    AdvanDx, Inc., 10a Roessler Rd, Woburn MA 01801-6208
  • Empresa matriz del fabricante (2017)
  • Source