Reported Feb 12, 2025 · Ongoing
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN:…
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc. · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
- The
- Rapid fFN Specimen Collection Tube (PN71550-001) is a component of the
- Rapid fFN Specimen Collection kit (PN71738-001)
- The Collection Tube (PN71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer
- Tubes are packaged into PN71738-00 at Hologic prior to kit release
- Lot codes and dates
Lot # 901164901165904850/
- UDI25420045514765
- Amount recalled
- 1351 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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