MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA TRICHOMONAS VAGINALIS ASSAY; APTIMA TRICHOMONAS VAGINALIS CONTROLS KIT; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

Catalog Number	303535
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, customer reported to hologic using improperly reconstituted aptima trichomonas vaginalis (atv) assay reagents.The atv kit was reconstituted on february 13, 2026, with the refrigerated components from master lot: 919757 and the room temperature components from ml 925885.This atv kit was then used for testing of patient samples on wl (b)(4) on panther sn#: (b)(6).This is considered off-label use of the atv assay.It is not known whether the results have been reported or if the samples will be retested or recollected.
Additional Manufacturer Narrative
Customer improperly reconstituted and used mismatched kits for testing of patient samples.Customer provided the logs from the 2 worklists but ts could not comment on the validity of the run or the sample results due to the off-label use.It is not known whether the results have been reported or if the samples will be retested or recollected.Hologic performed a risk assessment.There is no product impact.The issue is due to a reagent preparation error by the operator.Hologic has not learned of any adverse patient outcomes due to this event.

• Brand Name: APTIMA TRICHOMONAS VAGINALIS ASSAY; APTIMA TRICHOMONAS VAGINALIS CONTROLS KIT
• Common Device Name: TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
• 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: julia ford pulido ; 10210 genetic center drive; san diego, CA 92121 ; 8584108897
• MDR Report Key: 24592006
• Report Number: 2024800-2026-00013
• Device Sequence Number: 21095847
• Product Code: OUY
• UDI-Device Identifier: 15420045505537
• UDI-Public: 15420045505537
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122062
• 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): 03/12/2026

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: 303535
• Device Lot Number: 919757
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/13/2026
• 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