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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Rapid fFN for the TLi IQ system (Branded as FullTerm) see related information
Date Initiated by Firm December 15, 2009
Date Posted March 16, 2011
Recall Status1 Terminated 3 on March 16, 2011
Recall Number Z-1662-2011
Recall Event ID 54136
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: 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
Code Information Products made 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 2		 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.
PMA Database PMAs with Product Code = LKV and Original Applicant = HOLOGIC, INC.
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