MAUDE Adverse Event Report: HOLOGIC, INC. TLIIQ FETAL FIBRONECTIN TEST; ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Catalog Number	01200
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer noted that the sample in question was thick/mucoidal, which may impact results.Hologic provided customer with additional guidance regarding sample collection and handling.Customer reported there was no patient sample remaining, and they did not want to send the tliiq® analyzer or related materials back to hologic for investigation.Hologic has not been informed of any adverse patient outcomes related to this event.
Event or Problem Description
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.

• 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: grace nareau ; 10210 genetic center drive; san diego, CA 92121 ; 8584108040
• MDR Report Key: 24795580
• Report Number: 2024800-2026-00017
• Device Sequence Number: 8858497
• Product Code: LKV
• UDI-Device Identifier: 25420045501154
• UDI-Public: 25420045501154
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P920048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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 Catalogue Number: 01200
• Device Lot Number: B5913
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown