Class 2 Device Recall Rapid fFN Specimen Collection Kit; Rapid fFN Test Specimen Collection Kit

• Date Initiated by Firm: January 08, 2025
• Date Posted: February 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1095-2025
• Recall Event ID: 96116
• 510(K)Number: K900225
• Product Classification: Device, specimen collection - Product Code LIO
• Product: The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.
• Code Information: Lot # 901164, 901165, 904850/ UDI: 25420045514765
• FEI Number: 2024800
• Recalling Firm/ Manufacturer: Hologic, Inc.; 10210 Genetic Center Dr; San Diego CA 92121-4362
• For Additional Information Contact: Ryan Simon ; 858-275-0032 Ext. 128
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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
• Quantity in Commerce: 1351 units
• Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Guam and the countries of Canada and Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LIO