MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA CV/TV ASSAY; VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM

Catalog Number	ASY-11569
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, customer reported running previously tested negative samples with the aptima cv/tv assay on their panther instrument (sn (b)(6)) and receiving positive results from the same sample tubes.Customer did not provide further information on the nature of the samples, worklists, or the initial or retest results.Likewise, customer did not provide information on result reporting or patient treatment.Hologic has not been informed of any adverse patient outcomes related to this issue.
Additional Manufacturer Narrative
Customer originally contacted hologic to report a high trichomonas positivity rate when using aptima cv/tv assay lot 910984 on worklist (b)(4).Hologic reviewed customer logs and recommended the customer to perform cleaning and panel runs for contamination verification.After resolution of the observed high positivity rate, the customer reported that they ran these previously tested negative samples and received positive results.Customer did not provide log files for the discrepant samples and did not state for which analyte the initial negative and retest positive results were.Considering the customer originally expressed concern about their trichomonas results, hologic assumes the discrepant results were for the trichomonas analyte.Hologic attempted to contact customer on multiple occasions to gather further information on these samples and results with no response from the customer.Hologic has not been informed of any adverse patient outcomes related to this issue.

• Brand Name: APTIMA CV/TV ASSAY
• Common Device Name: VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM
• 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: 24581186
• Report Number: 2024800-2026-00010
• Device Sequence Number: 10326093
• Product Code: PQA
• UDI-Device Identifier: 15420045512061
• UDI-Public: 15420045512061
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K190472
• 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): 03/12/2026

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-11569
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/12/2026
• 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