BEUDAMED
    FDA Enforcement Class II Completed

    NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN, in carrier sealed in bag; f) BC30110, description: Calibration set, nanoDot; g) BC30141, description: nanoDot QC Set - Cs137 - Sale; h) BC30142, description: nanoDot Calibration set - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers

    Recall: Z-2573-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2573-2023
    Event ID
    92647
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Landauer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2023
    Initiation Date
    July 12, 2023
    Classification Date
    September 12, 2023
    Address
    2 Science Rd, Glenwood, IL, 60425-1531, United States

    Description

    NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot QC Set - 80kVp - Sale; c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; d) BC30088, description: nanoDot Calibration Set - 80kVp - No Charge; e) BC30095, description: Dot, D1DNN, in carrier sealed in bag; f) BC30110, description: Calibration set, nanoDot; g) BC30141, description: nanoDot QC Set - Cs137 - Sale; h) BC30142, description: nanoDot Calibration set - Cs137 - Sale; radiation monitoring dosimeter used with the microSTAR readers

    Reason

    LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.

    Code Info

    UDI/DI 0860003399903, all batch numbers

    Distribution

    Worldwide

    Quantity

    18333 units