Retiro De Equipo (Recall) de Device Recall Rapid fFN for the TLi IQ system (Branded as FullTerm)

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 Cytyc Prenatal Products/Hologic 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
    Enzyme immunoassay, fetal fibronectin - Product Code LKV
  • Causa
    Product name change requires conversion to a different type of pma and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.
  • Acción
    The firm, Hologic, sent a "Important-Product Recall/Correction" letter dated December 18, 2009 to its customers. The letter described the product, problem and the actions to be taken. The customers were instructed to 1) replace the directional inserts for the specimen collection kit and health care providers' brochure with provided instructions, 2) over-label specimen collection kit boxes with provided stickers and individual kits, 3) permanently destroy any marketing and educational materials with the "full term" name and 4) complete and return the CUSTOMER RECALL RESPONSE FORM via fax at 408-744-1905 or scan and email to If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).


  • Modelo / Serial
    Products made between 08/06/2009 and 11/25/2009
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1175 TLiIQ QCette ; manufactured by Hologic, Sunnyvale, CA. || Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in
  • Manufacturer


  • Dirección del fabricante
    Cytyc Prenatal Products/Hologic Inc., 1240 Elko Drive, Sunnyvale CA 94089-2212
  • Empresa matriz del fabricante (2017)
  • Source