Cytyc Prenatal Products/Hologic Inc.: 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 = 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.

Recall number

Z-1659-2011

Recalling firm

Cytyc Prenatal Products/Hologic Inc.

Product

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 = 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.

Status

Terminated

Initiated

2009-12-15

Posted

2011-03-16

Terminated

2011-03-16

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.

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 recallfullterm@hologic.com. If you have any questions about this notification, please contact the Hotline (800-442-9892, Option 7# or 508-263-8510).

Quantity

not on file

Distribution

Worldwide distribution.

Lot, serial or model codes

Products made between 08/06/2009 to 11/25/2009

510(k) numbers

not on file

PMA numbers

["P920048"]

Product code

LKV

Firm FEI

2024800

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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