Hologic, Inc.: Device Recall

Recall #Z-1095-2025 · 01/08/2025

Class II: Risk

Recall Details

Recall Number: Z-1095-2025
Classification: Class II
Product Type: Device
Recalling Firm: Hologic, Inc.
Status: Ongoing
Date Initiated: 01/08/2025
Location: San Diego, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1351 units

Reason for Recall

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.

Product Description

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.

Distribution Pattern

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, VA, WA, WI, WV, Guam and the countries of Canada and Japan.

Other Recalls by Hologic, Inc.

Class II: Risk 12/12/2025

Fungal contamination of affected lot with Parengyodontium album.
Class II: Risk 01/15/2025

Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Class II: Risk 12/13/2024

Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Class II: Risk 11/08/2024

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Class I: Dangerous 10/10/2024

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

View all recalls by Hologic, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.