Lower riskMedical device recall · FDA · Published January 8, 2025
Hologic Rapid fFN Specimen Collection Tubes Recall: Risk of Invalid Test Results
Hologic recalls specific lots of Rapid fFN Specimen Collection Tubes that may be empty or underfilled, causing invalid test results for preterm delivery risk assessment.
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.
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Contact the company
📍Recalling firmHologic, Inc.10210 Genetic Center Dr · San Diego, CA 92121-4362
“Hologic Rapid fFN Specimen Collection Tubes Recall: Risk of Invalid Test Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53139-hologic-rapid-ffn-specimen-collection-tubes-recall-risk-of-invalid. Based on FDA recall #Z-1095-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1095-2025%22&limit=1).
The FDA announced on Jan. 8, 2025, that Hologic, Inc. is recalling specific lots of the Rapid fFN Specimen Collection kit due to potential filling errors. The hazard involves tubes that may be empty, underfilled, or overfilled with extraction buffer.
The transport tubes may be empty, underfilled, or overfilled with extraction buffer. This defect can result in invalid results, delays in obtaining results, false positive results from underfilled tubes, or false negative results from overfilled tubes.
Context
GovInfoNow's records show Hologic, Inc. has had 30 other recalls on record since June 27, 2017. Recent brand recalls include a Feb. 18, 2026, Aptima HPV Assay Kit recall for false negative results risk and a March 23, 2026, Genius Review Station Display recall for user modifications risk safety. Other recent recalls of similar products include the LH One Step Ovulation Test Device Recall (Nov. 22, 2025), Exploro Fertility Test Recall (Nov. 22, 2025), and Menopause Test Cassette Recall (Nov. 22, 2025).
How to tell if you have this one
Check the lot numbers: 901164, 901165, or 904850. The tubes have a unique identifier (UDI) starting with 25420045514765.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Tube Lot Number
Look for lot numbers 901164, 901165, or 904850 on the tube packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 47 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1095-2025 (January 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1095-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.