BEUDAMED
    FDA Enforcement Class II Ongoing

    CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001

    Recall: Z-1345-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1345-2022
    Event ID
    90417
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Menarini Silicon Biosystems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 13, 2022
    Initiation Date
    May 20, 2022
    Classification Date
    July 7, 2022
    Address
    3401 Masons Mill Rd Ste 100, N/A, Huntingdon Valley, PA, 19006-3574, United States

    Description

    CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001

    Reason

    High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

    Code Info

    UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022

    Distribution

    CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,

    Quantity

    484 units