MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA COMBO 2 ASSAY; DNA-REAGENTS, NEISSERIA

Catalog Number	ASY-13823
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No system log files or additional supporting documentation were provided by the customer for review by hologic technical support.
Event or Problem Description
On 8 may 2026, a customer in finland reported to hologic that discrepant result was generated whilst using the ac2 assay with panther instrument (serial number: (b)(6).On (b)(6) 2026, sample was tested in panther and generated a chlamydia trachomatis (ct) positive/neisseria gonorrhoea (gc) negative result.The same sample was retested on (b)(6) on the panther instrument and generated a chlamydia trachomatis (ct) positive/neisseria gonorrhoeae (gc) positive result.On (b)(6) 2026, sample was tested in panther and generated a chlamydia trachomatis (ct) negative/neisseria gonorrhoea (gc) positive result.The same sample was retested on 22 april on the panther instrument and generated a chlamydia trachomatis (ct) positive/neisseria gonorrhoeae (gc) positive result.Mas requested logs.No system log files or additional supporting documentation were provided by the customer for review by hologic technical support yet.

• Brand Name: APTIMA COMBO 2 ASSAY
• Common Device Name: DNA-REAGENTS, NEISSERIA
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC INC.; 120210 genetic center drive; san diego CA 92121
• Manufacturer Contact: julia ford pulido ; 120210 genetic center drive; san diego, CA 92121 ; 8584108897
• MDR Report Key: 25309482
• Report Number: 2024800-2026-00024
• Device Sequence Number: 18601483
• Product Code: LSL
• UDI-Device Identifier: 15420045512832
• UDI-Public: 15420045512832
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K111409
• 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): 05/27/2026

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: ASY-13823
• 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: 05/08/2026
• Initial Report FDA Received Date: 05/27/2026
• 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