BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0410-2019 · Initiated September 11, 2018

    Recall

    Recall Number
    Z-0410-2019
    Event Number
    81121
    Firm
    R & D Systems, Inc.
    FEI Number
    2182501
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    September 11, 2018
    Terminated
    September 1, 2020
    Address
    614 McKinley Pl NE, Minneapolis, MN, 55413-2610

    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.

    Action

    The firm contacted the consignees (end users) by telephone on 09/11/2018 to alert them of the issue. The firm followed with an email on 09/21/2018 restating the issue and offering to replace any unused kits.

    Distribution

    IA and CO

    Quantity

    8 kits