MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA HPV SCREENING ASSAY; KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS

Catalog Number	302883
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a customer in canada reported to hologic that they had discrepant results for 2 aliquots of the same source sample tested in triplicate with the aptima hpv assay kit run on the panther plus instrument sn: (b)(6).On (b)(6) 2026, while performing a new assay kit lot validation, sample id: (b)(6) was tested using hpv assay kit master lot (ml) 921025 and initially resulted hpv positive, then positive and negative upon retesting in worklist id: (b)(4).Sample id: (b)(6) was tested using hpv assay kit ml 927271 and initially resulted hpv positive, then negative and negative upon retesting in worklist id: (b)(4).The customer expected the result to be negative based on previous testing.Logs for previous tests were not provided, and it is not clear whether these previous runs were using the same sample tube.
Additional Manufacturer Narrative
Hologic reviewed the panther system logs and observed no signs of hardware failure or reagent preparation issues for worklist id: (b)(4).The issue appeared to be sample related, most likely due to a low target concentration or sample mishandling.Hologic has not learned of any patient treatment or adverse patient outcomes due to this event.

• Brand Name: APTIMA HPV SCREENING ASSAY
• Common Device Name: KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS
• 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: 24732950
• Report Number: 2024800-2026-00016
• Device Sequence Number: 16018668
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100042
• 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): 03/30/2026

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: 302883
• Device Lot Number: 927271, 921025
• 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: 03/17/2026
• Initial Report FDA Received Date: 03/30/2026
• 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