Rapid fFNRecalls & reported problems across all models

We found 2 models of Rapid fFN by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2022 and Sep 25, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Rapid fFN recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 8, 2025Open, 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 ↗

Most reported Rapid fFN problems

Rapid fFN models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Rapid fFN FFN SPECIMEN COLLECTION KIT, 25PK

  Device, specimen collection
  1 recall0 reports
• Rapid fFN® KIT, RAPID FFN 26 CASSETTE TLIIQ SYSTEM

  ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
  4 reports

Recent Rapid fFN adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Imprecise or Erratic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900584 ↗
• InjuryApr 6, 2026Imprecise or Erratic Results

  ON (B)(6) 2026, CUSTOMER REPORTED RECEIVING DISCREPANT FETAL FIBRONECTIN (FFN) PATIENT RESULTS WHILE USING THE RAPID FFN® CASSETTES (LOT B5913) ON THEIR TLIIQ® ANALYZER (SN (B)(6). THE INITIAL SAMPLE RESULT WAS POSITIVE, AND THE SAME SAMPLE WAS RUN AGAIN TWICE WITHIN TWO HOURS OF THE INITIAL TEST. BOTH RETEST RESULTS WERE NEGATIVE, USING THE SAME CASSETTE LOT (B5913). CUSTOMER CONFIRMED THAT THE DAILY QC (QCETTE SN (B)(6) AND LIQUID CONTROLS (POSITIVE CONTROL LOT 921415; NEGATIVE CONTROL LOT 921416) PASSED WITHOUT ISSUES. CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE PATIENT, REASON FOR SAMPLE RETEST, OR RESULTS REPORTING. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795580 ↗
• InjuryMay 30, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  FOLLOW-UP REPORT. SEE SECTION H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115705 ↗
• InjuryOct 19, 2022False Negative Result; False Negative Result

  ON JANUARY 06, 2018 HOLOGIC FILED A PROBLEM REPORT WITH HEALTH CANADA AND ASSESSED THAT ONE WAS NOT NEEDED FOR US. HOWEVER, BASED ON FDA FEEDBACK FROM A RECENT INSPECTION, HOLOGIC DECIDED TO FILE A MDR FOR THE EVENT. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE PATIENT PRESENTED AT 29 WEEKS ON (B)(6) 2017 WITH SYMPTOMS OF PRETERM LABOUR. A FETAL FIBRONECTIN SWAB WAS COLLECTED @ 1429 HRS WITHOUT THE USE OF A SPECULUM BUT FOLLOWING THE GUIDELINES OF COLLECTING THE SWAB FROM THE POSTERIOR FORNIX FOR 10 SECONDS. THE TEST WAS RUN AND IT REPORTED NEGATIVE. THE PATIENT WAS DISCHARGED ONLY TO RETURN IN OBVIOUS ACTIVE LABOUR. PATIENT DELIVERED THE SAME DAY AT 2339 HRS. HOLOGIC WAS MADE AWARE OF THIS ISSUE ON DECEMBER 20, 2017.

  Patient problems: Premature Labor

  MAUDE report 15635976 ↗

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