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Rapid fFN recallZ-1095-2025 · Hologic, Inc. · initiated Jan 8, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-1095-2025
Status
Open, Classified
Initiated by the company
Jan 8, 2025
Posted by the FDA
Feb 4, 2025
Recalling firm
Hologic, Inc.
Quantity
1351 units
Product code
LIO
FDA submissions
K900225
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 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.

Code information (models, lots, serial numbers)

Lot # 901164, 901165, 904850/ UDI: 25420045514765

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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