MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA UNISEX SWAB SPECIMEN COLLECTION KIT; DNA-REAGENTS, NEISSERIA

Catalog Number	301041-01
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hologic informed customer that use of an aptima unisex swab specimen collection kit for endocervical and male urethral swab specimens after the expiration date was considered off label use and that expired kits should be discarded.Hologic performed a risk assessment for this issue and determined that as a sample was collected in an expired sample transfer tube, there is a potential risk for a false negative result due to inadequate sample lysis and/or inadequate ph buffering.Hologic has not been informed of any adverse patient outcomes related to this issue.H3 other text : other.
Event or Problem Description
On (b)(6) 2026, customer reported that a sample was collected on (b)(6) 2026, with an aptima unisex swab specimen collection kit for endocervical and male urethral swab specimens that had expired on january 31, 2026.Customer noted the affected sample was sent out for testing with the aptima combo 2 assay and indicated other samples may have been collected in expired kits and sent for testing as well.Customer was unsure how many samples may be affected.Customer did not provide lot information as they had discarded affected tubes.Customer did not report any issues with sample results and did not provide further information on patient information/treatment or results reporting.Hologic has not been informed of any adverse patient outcomes related to this issue.

• Brand Name: APTIMA UNISEX SWAB SPECIMEN COLLECTION KIT
• 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: grace nareau ; 10210 genetic center drive; san diego, CA 92121 ; 8584108040
• MDR Report Key: 24444520
• Report Number: 2024800-2026-00006
• Device Sequence Number: 10254502
• Product Code: LSL
• UDI-Device Identifier: 25420045506272
• UDI-Public: 25420045506272
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 301041-01
• Device Lot Number: N/A
• 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: 02/02/2026
• Initial Report FDA Received Date: 02/25/2026
• 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
• Patient Sex: Unknown