BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUEST INHIBITION ASSAY

    MDR report key: 23819175 · Received December 16, 2025

    Report

    Report Number
    MW5180611
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    August 16, 2025
    Report Date
    December 8, 2025
    Manufacturer
    QUEST DIAGNOSTICS
    Product Code
    PGI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 4/22/2026 FOR REPORT MW5180611 TO UPDATE PROCODE PGI.

    Description of Event or Problem · 0

    PATIENT HAD A FALSE POSITIVE HSV-2 TEST RESULT. PATIENT TESTED POSITIVE FOR HSV-2 ON A DIASORIN LIAISON XL HSV-2 IGG TEST AT QUEST DIAGNOSTICS. PATIENT ALSO TESTED POSITIVE ON QUEST INHIBITION ASSAY. PATIENT RECEIVED A CONFIRMATORY TEST VIA (B)(6) WESTERN BLOT WHICH WAS NEGATIVE. PATIENT CODE: 4582. DEVICE CODE: 1227. PROCODE-JJX. REFERENCE REPORT: MW5180610.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274849 QUEST INHIBITION ASSAY HERPES VIRUS (VZV, HSV1, HSV2), DNA DETECTION ASSAY FOR CUTANEOUS AND MUCOCUTANE PGI QUEST DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female