BEUDAMED
    FDA Enforcement Class II 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 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1603-2023
    Event ID
    92131
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    IMMUNDIAGNOSTIK, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 24, 2023
    Initiation Date
    March 27, 2023
    Classification Date
    May 17, 2023
    Address
    400 Bedford St Ste 104, N/A, Manchester, NH, 03101-1195, United States

    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

    Code Info

    UDI: (01) 04050598000582 PN K6870/Lot Numbers: 220706 Exp. 05/04/2024; 221122 Exp. 06/07/2024. P/N:K6870.20.US.L Lot Numbers: 221124 Exp:07/29/2025, 230102 Exp: 10/24/2025

    Distribution

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

    Quantity

    88 units