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

Catalog Number	902615
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
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.While the cause of the observed discrepant results is unknown, it is possible the string of nine discrepant results was due to kit or environmental contamination in the lab.Hologic review did not show indication of instrument contamination.Hologic has not been informed of any adverse patient outcomes related to this issue.H3 other text: other.
Event or Problem Description
On january 6, 2026, customer reported that they received discrepant results on nine samples while using the aptima combo 2 (ac2) assay (ml 924882) on their panther plus instrument ((b)(6)).On (b)(6) 2026, customer initially tested the nine samples on ac2 worklist (wl) (b)(4) and received a ct positive/ gc positive result on sample id (b)(6) and ct negative/gc negative results on the other eight sid¿s; (b)(6).Customer suspected environmental contamination and re-ran the samples in question using a newly reconstituted assay kit.Customer performed a retest of all nine samples on worklist ids (wl) (b)(4) and (wl) (b)(4) and received a ct negative/gc positive result on sample id ((b)(6)) and ct positive/gc negative results on sid; (b)(6).Customer reported out the results from the initial wl (b)(4).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: amy holtgraver ; 10210 genetic center drive; san diego, CA 92121 ; 8584108236
• MDR Report Key: 24257644
• Report Number: 2024800-2026-00004
• Device Sequence Number: 8327230
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/04/2026

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 Catalogue Number: 902615
• 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: 01/06/2026
• Initial Report FDA Received Date: 02/04/2026
• 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