Recall Z-1658-2011 ยท LKV Enzyme Immunoassay, Fetal Fibronectin
Cytyc Prenatal Products/Hologic Inc.
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 ri
| Date | Mar 16, 2011 (initiated Dec 15, 2009) |
| Status | Terminated |
| 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 |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900225 | ROMCHECK SPECIMEN COLLECTION KIT Adeza Biomedical, Feb 2, 1990 |