BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 20, 2022

    Recall

    Recall Number
    Z-1345-2022
    Event Number
    90417
    Firm
    Menarini Silicon Biosystems
    FEI Number
    3004153557
    Product Code
    NQI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 20, 2022
    Address
    3401 Masons Mill Rd, Ste 100, Huntingdon Valley, PA, 19006-3574

    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

    Action

    Menarini Silicon Biosystems issued notification telephone Urgent Medical Device Correction Notification CTC Kit Lot S108 to US on 5/20/22. Followed by e-mail direct to consignees for US sites - May 23, 2022 and Coordination with Asia Pacific region and the EU with Local QA and RA from the regions. Letter states reason for recall, health risk and action to take: Discontinue usage of Lot S108 and quarantine the lot in your inventory for disposal. Review patient samples run with Kit Lot S108 which had results that were above the cut-off. If you observe any images with the staining pattern of the false positive images shown below or there is any uncertainty regarding these images impacting the patient's outcome from below the cutoff to above the cut-off, the patient sample should be repeated. Report any previous occurrence of unusually high number of total images/ unassigned events or potential false positive events that have not already been reported to the Customer Technical Support. " Complete and return the enclosed Confirmation of Receipt form no later than May 31, 2022. If you have additional questions about this issue, contact Customer Technical Support at +1-877-837-4339 option 2

    Distribution

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

    Quantity

    484 units