BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS AT HOME COVID-19 TEST KIT

    MDR report key: 23885117 · Received December 23, 2025

    Report

    Report Number
    0002024674-2025-00636
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 23, 2025
    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 PRODUCT DID NOT FIND ANY UNUSUAL TREND FOR THE REPORTED COMPLAINT CATEGORY. WITHOUT A LOT NUMBER, NO FURTHER INVESTIGATION CAN BE CONDUCTED. ROOT CAUSE: INSUFFICIENT INFO, SOURCE: EMAIL.

    Description of Event or Problem · 0

    REPORTS "HAVING SIDE EFFECTS FROM THE WALGREENS COVID TESTING". INFORMATION RECEIVED VIA EMAIL. CUSTOMER UNRESPONSIVE TO MULTIPLE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION VIA BOTH PHONE AND EMAIL. NO APPARENT ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801334 WALGREENS AT HOME COVID-19 TEST KIT WALGREENS AT HOME COVID-19 TEST KIT QKP QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS 311917122045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown