FDA Device recall Z-1095-2025
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001)
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001) by Hologic, citing 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 extrac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1095-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-08 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hologic |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot # 901164, 901165, 904850/ UDI: 25420045514765 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1095-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.