BEUDAMED
    FDA Enforcement Class III Terminated

    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971

    Recall: Z-0410-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0410-2019
    Event ID
    81121
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    R & D Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 14, 2018
    Initiation Date
    September 11, 2018
    Classification Date
    November 8, 2018
    Termination Date
    September 1, 2020
    Address
    614 McKinley Pl NE, Minneapolis, MN, 55413-2610, United States

    Description

    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971

    Reason

    The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.

    Code Info

    Manufacturing Lot # 182801

    Distribution

    IA and CO

    Quantity

    8 kits