Hologic, Inc.: 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.

Recall number

Z-1095-2025

Recalling firm

Hologic, Inc.

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.

Status

Open, Classified

Initiated

2025-01-08

Posted

2025-02-04

Terminated

not on file

Reason

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.

Root 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

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.

Lot, serial or model codes

Lot # 901164, 901165, 904850/ UDI: 25420045514765

510(k) numbers

["K900225"]

PMA numbers

not on file

Product code

LIO

Firm FEI

2024800

Firm city

San Diego

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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