Rapid fFN FFN SPECIMEN COLLECTION KIT, 25PKRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K900225); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 8, 2025Class IIOpen, Classified

   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.

   Z-1095-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900225. One submission often covers many models, so check the product and lot details in each record.

• Z-1658-2011 · Dec 15, 2009 · Terminated
  Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797 Specimen Collection Kit (8 pack); manufactured by Hologic, Sunnyvale, CA. Medica