Z-1662-2011

Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1175 TLiIQ...

Name: Z-1662-2011 Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1175 TLiIQ...
Creator: Cytyc Prenatal Products/Hologic Inc.
Published: 2009-12-15
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2009-12-15 / Terminated

FDA source

Cytyc Prenatal Products/Hologic Inc. began a recall of Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1175 TLiIQ QCette ; manufactured by Hologic, Sunnyvale, CA... on 2009-12-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1662-2011
Status: Terminated
Initiated: 2009-12-15
Posted: 2011-03-16
Terminated: 2011-03-16
Recalling firm: Hologic, Inc.
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 = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.
Product code: LKV Enzyme Immunoassay, Fetal Fibronectin
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 root 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 [email protected]. If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).
Distribution: Worldwide distribution.
Product codes and lots: Products made between 08/06/2009 and 11/25/2009

Product code LKV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)