BEUDAMED
    FDA Recall Terminated

    CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

    Recall: Z-1530-2018 · Initiated April 4, 2018

    Recall

    Recall Number
    Z-1530-2018
    Event Number
    79872
    Firm
    Menarini Silicon Biosystems
    FEI Number
    3004153557
    Product Code
    NQI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 4, 2018
    Terminated
    April 9, 2019
    Address
    3401 Masons Mill Rd, Ste 100, Huntingdon Valley, PA, 19006-3574

    Description

    CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

    Reason

    Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.

    Action

    Menarini silicon biosystems sent an Urgent Medical Device Correction Notification dated April 3, 2018. Required Actions. " Please dispose of any affected product in your current inventory . " Report any previous occurrence of unusually high number of total images I unassigned events in patient samples to Customer Technical Support. " Complete and return the enclosed Confirmation of Receipt form no later than April 20,2018. For further question, please call (215) 830-0777.

    Distribution

    Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy