Rapid fFN® KIT, RAPID FFN 26 CASSETTE TLIIQ SYSTEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 25420045501154), 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).

8 other recalls cover devices cleared under the same FDA submission (P920048); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P920048. One submission often covers many models, so check the product and lot details in each record.

• Z-0676-2018 · Nov 29, 2017 · Terminated
  Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
• Z-0677-2018 · Nov 29, 2017 · Terminated
  Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
• Z-1663-2011 · Dec 15, 2009 · Terminated
  Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1202 TLiIQ Analyzer Boxed Set (includes Analyzer/Printer and QCette). manufactured by
• Z-1662-2011 · Dec 15, 2009 · Terminated
  Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1175 TLiIQ QCette ; manufactured by Hologic, Sunnyvale, CA. Medical device for use i
• Z-1660-2011 · Dec 15, 2009 · Terminated
  Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 01200/1200Q Rapid fFN Cassette Kit; manufactured by Hologic, Sunnyvale, CA. Medica
• Z-1661-2011 · Dec 15, 2009 · Terminated
  Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 01166 Rapid fFN Control Kit ; manufactured by Hologic, Sunnyvale, CA. Medical device
• Z-1658-2011 · Dec 15, 2009 · Terminated
  Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797 Specimen Collection Kit (8 pack); manufactured by Hologic, Sunnyvale, CA. Medica
• Z-1659-2011 · Dec 15, 2009 · Terminated
  Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 71738 Specimen Collection Kit (25 pack); manufactured by Hologic, Sunnyvale, CA. Med