Z-1095-2025Class II

The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection...

Name: Z-1095-2025 The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection...
Creator: Hologic, Inc.
Published: 2025-01-08
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2025-01-08 / Open, Classified / root cause: manufacturing process

FDA source

Hologic, Inc. began a recall of 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... on 2025-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1095-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-08
Posted: 2025-02-04
Recalling firm: Hologic, Inc.
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.
Product code: LIO Device, Specimen Collection
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hologic issued a "Urgent: Medical Device Recall Notification on January 8, 2025 via FedEx. Hologic asked consignees to take the following actions: 1. Please discontinue use of the Rapid fFN Specimen Collection Kit Catalog Number: 71738-001; 2. Please segregate and count how many of the affected Rapid fFN Specimen Collection Kit Catalog Number: 71738-001; 3. Please fill out the Customer Response Form (CRF); 4. Hologic will process and ship the replacement kits as listed on the completed CRF once it has been received; 5. For tests already administered from the affected product lots and if the patient has not given birth, it is at the discretion of the healthcare providers to notify patients who were managed based on a number of clinical decision points including but not exclusive to fetal fibronectin test results. If the patient has given birth, no further action is required.; 6. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support
Quantity in commerce: 1351 units
Distribution: 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.
Product codes and lots: Lot # 901164, 901165, 904850/ UDI: 25420045514765

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1095-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1095-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-04

Product code LIO

K900225Class IRomcheck Specimen Collection KitAdeza Biomedical / cleared 1990-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)