MAUDE Adverse Event Report: Hologic, Inc. TLiIQ Fetal Fibronectin Test; ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Model Number	KIT, RAPID FFN 26 CASSETTE TLIIQ SYSTEM
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury

• Brand Name: TLiIQ Fetal Fibronectin Test
• Common Device Name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
• Manufacturer (Section D): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: zachary hansen ; 10210 genetic center drive; san diego, CA 92121 ; +1(951)973-9240
• MDR Report Key: 50900584
• Report Number: 2024800-2026-00076
• Device Sequence Number: 17651698
• Product Code: LKV
• UDI-Device Identifier: 25420045501154
• UDI-Public: 25420045501154
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: KIT, RAPID FFN 26 CASSETTE TLIIQ SYSTEM
• Device Catalogue Number: 01200
• Device Lot Number: E5914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown