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.
Hologic is recalling three lots of Rapid fFN Specimen Collection Tubes that may be empty, underfilled, or overfilled with extraction buffer. This can lead to invalid test results or false positives/negatives for preterm delivery risk assessment.
The tubes may be empty or underfilled with extraction buffer, causing invalid test results. Underfilled tubes can cause false positive results, while overfilled tubes can cause false negative results for preterm delivery risk assessment.
Pregnant women using the Rapid fFN Specimen Collection kit for preterm delivery risk assessment are most at risk if they use the recalled tubes.
Check the lot numbers: 901164, 901165, or 904850. The tubes have a unique identifier (UDI) starting with 25420045514765.
Look for lot numbers 901164, 901165, or 904850 on the tube packaging.
Using empty or underfilled tubes can cause invalid test results or false positive results, while overfilled tubes may cause false negative results for preterm delivery risk assessment.
Check the lot numbers: 901164, 901165, or 904850. The tubes have a unique identifier (UDI) starting with 25420045514765.
No action is required if you have the correct lot numbers. Only check the lot numbers to ensure you have a safe tube.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-1095-2025 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-1095-2025 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
