MAUDE Adverse Event Report: Hologic, Inc. Aptima Combo 2 Assay; DNA-REAGENTS, NEISSERIA

Model Number	ASY-15648
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury

• Brand Name: Aptima Combo 2 Assay
• Common Device Name: DNA-REAGENTS, NEISSERIA
• Manufacturer (Section D): Hologic, Inc.; 10210 genetic center drive; san diego CA 9212
• Manufacturer (Section G): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: asha dunigan ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 50625130
• Report Number: 2024800-2026-00070
• Device Sequence Number: 13402775
• Product Code: LSL
• UDI-Device Identifier: 15420045514973
• UDI-Public: 15420045514973
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K200436
• 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): 09/04/2026

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 Model Number: ASY-15648
• Device Lot Number: 939478
• 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: Not provided
• Initial Report FDA Received Date: 09/05/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown