Class 2 Device Recall Rapid fFN for the TLi IQ system (Branded as FullTerm)

• Date Initiated by Firm: December 15, 2009
• Date Posted: March 16, 2011
• Recall Status: Terminated on March 16, 2011
• Recall Number: Z-1658-2011
• Recall Event ID: 54136
• 510(K)Number: K900225
• PMA Number: P920048
• Product Classification: Enzyme immunoassay, fetal fibronectin - Product Code LKV
• Product: Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797 Specimen Collection Kit (8 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
• Code Information: Products produced between 08/06/2009 and 11/25/2009.
• Recalling Firm/ Manufacturer: Cytyc Prenatal Products/Hologic Inc.; 1240 Elko Drive; Sunnyvale CA 94089-2212
• For Additional Information Contact: 408-745-5128 Ext. 128
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: PMA
• 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).
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LKV
• PMA Database: PMAs with Product Code = LKV