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	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a customer in united kingdom reported to hologic that a discrepant result was generated whilst using the ac2 assay (master lot: 930679) with panther instrument (serial number: (b)(6).The incident was recorded under hologic reference number cpt-02110133.On (b)(6) 2026, sample id (b)(6) was tested in panther worklist id (b)(6) and generated a chlamydia trachomatis (ct) negative / neisseria gonorrhea (gc) negative result.The same sample (id (b)(6) was retested on another panther instrument and generated a neisseria gonorrhoeae (gc) positive result.Later, the sample was retested again on the panther instrument and generated a neisseria gonorrhea (gc) negative result.No information regarding patient treatment is available at this time.Hologic has not been informed of any adverse patient outcome related to this event.
Additional Manufacturer Narrative
Hologic reviewed the panther system log files provided by the customer.The preliminary analysis indicates that the discrepant result may be due to external introduction of material after the sample was tested on the panther system, or potential cross-contamination during sample handling and processing.Review of the logs did not reveal any hardware or instrument issues that contributed to the discrepant result.Hologic has not been informed of any adverse patient outcomes related to this event.

• 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: 25895851
• Report Number: 2024800-2026-00046
• Device Sequence Number: 15907252
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/21/2026

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: 930679
• 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: 07/21/2026
• 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