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	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed the panther logs and worklists and noted there were no indications of hardware or reagent preparation issues that affected results.The issue appeared to be sample related, most likely due to low target concentration or sample mishandling.Hologic has not learned of any patient treatment or adverse patient outcomes due to this event.
Event or Problem Description
On (b)(6) 2026, customer reported receiving discrepant results while using the aptima combo 2 (ac2) assay (ml 924882) on their panther plus instrument (sn (b)(6).On (b)(6) 2026, customer initially tested 15 samples on ac2 worklist (wl) (b)(6) and received a ct positive/gc negative result on seven samples, and ct negative/gc negative results on the other eight samples.Customer was concerned about a cluster of six ct positive/gc negative samples and re-tested all 15 samples using the same ac2 assay kit.The repeat(b)(6) contained discrepant results on five samples: sid (b)(6) resulted ct negative/gc negative (originally ct positive/gc negative) and sid (b)(6) resulted ct positive/gc negative (originally ct negative/gc negative).Customer reported the ct negative/gc negative results from the repeat (b)(6) customer did not provide any information on the patient or patient treatment.Hologic has not been informed of any adverse patient outcomes related to this issue.

• 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.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: maria osorio ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 24860717
• Report Number: 2024800-2026-00019
• Device Sequence Number: 15705504
• Product Code: LSL
• UDI-Device Identifier: 15420045512832
• UDI-Public: 15420045512832
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 04/13/2026

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
• Device Lot Number: 924882
• 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: 04/13/2026
• 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