BEUDAMED
    FDA Recall Completed

    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates

    Recall: Z-1603-2023 · Initiated March 27, 2023

    Recall

    Recall Number
    Z-1603-2023
    Event Number
    92131
    Firm
    IMMUNDIAGNOSTIK, Inc
    FEI Number
    3015189693
    Product Code
    DEG
    Status
    Completed
    Root Cause
    No Marketing Application
    Initiated
    March 27, 2023
    Posted
    May 18, 2023
    Address
    400 Bedford St, Ste 104, Manchester, NH, 03101-1195

    Description

    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates

    Reason

    Marketed without a 510k

    Action

    Immundiagnostik initiated the recall on Monday March 27, 2023 via email/telephone. Letter Urgent: Field Corrective Action Product Recall, states reason for recall, health risk and action to take: Effective immediately, we ask that you discard all unused kits of the IDK Lactoferrin ELISA and discontinue use of the product pending clarification by the FDA. If you have any questions related to this letter or the response, please contact IDK customer support at (888) 433-9020 x1006

    Distribution

    US Nationwide Distribution: CA, IL, NC, NH, OR

    Quantity

    88 units