BEUDAMED
    FDA Recall Completed

    Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; radiation monitoring dosimeter used with the microSTAR readers

    Recall: Z-2566-2023 · Initiated July 12, 2023

    Recall

    Recall Number
    Z-2566-2023
    Event Number
    92647
    FEI Number
    3008426232
    Product Code
    IYE
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    July 12, 2023
    Posted
    September 12, 2023
    Address
    Landauer 2 Science Rd, Glenwood, IL, 60425-1531

    Description

    Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; 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.

    Action

    Landauer disseminated an URGENT - Medical Device Recall notice to its consignees on 07/12/2023 by US mail and email. The notice explained the problem with the devices, potential risk, and requested the following: Discontinue use of the affected products, destroy used products, and return unused products.

    Distribution

    Worldwide

    Quantity

    13294 units