BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS AT HOME COVID-19 TEST KIT

    MDR report key: 25243522 · Received May 21, 2026

    Report

    Report Number
    0002024674-2026-00083
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 21, 2026
    Manufacturer
    QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    QKP
    UDI-DI
    311917122045
    PMA / PMN Number
    EUA210269/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF THE PACKAGE INSERT (PI) WAS CONDUCTED FOR CLARITY OF INSTRUCTIONS. NO ISSUES WERE FOUND. THE CUSTOMER'S REPORTED PROBLEM WAS RELATED TO A DEVIATION FROM THE INSTRUCTIONS CALLED OUT IN THE PI. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTS INSERTING SWAB INTO NOSTRIL AFTER INSERTING INTO THE REAGENT. NO APPARENT ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214367 WALGREENS AT HOME COVID-19 TEST KIT WALGREENS AT HOME COVID-19 TEST KIT QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS K3773763 311917122045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown