BEUDAMED
    FDA Enforcement Class II 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 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1530-2018
    Event ID
    79872
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Menarini Silicon Biosystems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    April 4, 2018
    Classification Date
    April 26, 2018
    Termination Date
    April 9, 2019
    Address
    3401 Masons Mill Rd Ste 100, N/A, Huntingdon Valley, PA, 19006-3574, United States

    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.

    Code Info

    UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)

    Distribution

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

    Quantity

    N/A