Hologic, Inc. recalls The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN…

Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN¿ for the TLiIQ¿ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.

Hologic issued a "Urgent: Medical Device Recall Notification on January 8, 2025 via FedEx. Hologic asked consignees to take the following actions: 1. Please discontinue use of the Rapid fFN Specimen Collection Kit Catalog Number: 71738-001; 2. Please segregate and count how many of the affected Rapid fFN Specimen Collection Kit Catalog Number: 71738-001; 3. Please fill out the Customer Response Form (CRF); 4. Hologic will process and ship the replacement kits as listed on the completed CRF once it has been received; 5. For tests already administered from the affected product lots and if the patient has not given birth, it is at the discretion of the healthcare providers to notify patients who were managed based on a number of clinical decision points including but not exclusive to fetal fibronectin test results. If the patient has given birth, no further action is required.; 6. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support

• FDA enforcement recordOfficial FDA database entry for Z-1095-2025
• FDA 510(k) clearance · K900225The device's official FDA premarket clearance record
• FDA device classification · LIOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2900The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hologic, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.