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Rapid fFN for the TLi IQ system and specimen collection kit… recallZ-1659-2011 · Cytyc Prenatal Products/Hologic Inc. · initiated Dec 15, 2009

Terminated All recalls posted in March 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cytyc Prenatal Products/Hologic Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: PMA

What the company is doing

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).

Recall details

Recall number
Z-1659-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 15, 2009
Posted by the FDA
Mar 16, 2011
Recalling firm
Cytyc Prenatal Products/Hologic Inc.
Product code
LKV
FDA submissions
P920048
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 = 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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under P920048 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 54136).

Sources and updates

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