Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cytyc Prenatal Products/Hologic Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54136
  • Event Risk Class
    Class 2
  • Event Number
    Z-1659-2011
  • Event Initiated Date
    2009-12-15
  • Event Date Posted
    2011-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87604
  • Notes / Alerts
    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.
  • Extra notes in the data
    Enzyme immunoassay, fetal fibronectin - Product Code LKV
  • Reason
    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)
  • Model / Serial
    Products made between 08/06/2009 to 11/25/2009
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 71738 Specimen Collection Kit (25 pack); 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.
  • Manufacturer Address
    Cytyc Prenatal Products/Hologic Inc., 1240 Elko Drive, Sunnyvale CA 94089-2212
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA