Events

Rappel de Device Recall Rapid fFN for the TLi IQ system (Branded as FullTerm)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Cytyc Prenatal Products/Hologic Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    54136
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1662-2011
  • Date de mise en oeuvre de l'événement
    2009-12-15
  • Date de publication de l'événement
    2011-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87607
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Enzyme immunoassay, fetal fibronectin - Product Code LKV
  • Cause
    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.
  • Action
    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 recallfullterm@hologic.com. If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).

Device

Device Recall Rapid fFN for the TLi IQ system (Branded as FullTerm)
  • Modèle / numéro de série
    Products made between 08/06/2009 and 11/25/2009
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    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
    Cytyc Prenatal Products/Hologic Inc.

Manufacturer

Cytyc Prenatal Products/Hologic Inc.
  • Adresse du fabricant
    Cytyc Prenatal Products/Hologic Inc., 1240 Elko Drive, Sunnyvale CA 94089-2212
  • Société-mère du fabricant (2017)
    Hologic Inc
  • Source
    USFDA