BEUDAMED
    FDA Recall Open, Classified

    ColoSense Test Kit, Part No. 80-001, component of ColoSense test

    Recall: Z-2077-2025 · Initiated May 20, 2025

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    Recall

    Recall Number
    Z-2077-2025
    Event Number
    97017
    Firm
    Geneoscopy, Inc.
    FEI Number
    3026996410
    Product Code
    SBB
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    May 20, 2025
    Posted
    July 3, 2025
    Address
    2220 Welsch Industrial Ct, Saint Louis, MO, 63146-4222

    Description

    ColoSense Test Kit, Part No. 80-001, component of ColoSense test

    Reason

    Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.

    Action

    On May 20, 2025, the firm initiated a voluntary removal of the affected test kit lot. An internal recall notification was sent to the affected CLIA Laboratory Director. All remaining test kits were removed from the CLIA laboratory. The firm's investigation of the root cause for this issue is ongoing.

    Distribution

    US Nationwide distribution in the state of Missouri.

    Quantity

    10 units