BEUDAMED
    FDA Recall Terminated

    Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.

    Recall: Z-2407-2020 · Initiated March 20, 2020

    Recall

    Recall Number
    Z-2407-2020
    Event Number
    85660
    Firm
    Utak Laboratories Inc
    FEI Number
    2022375
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 20, 2020
    Terminated
    July 22, 2020
    Address
    25020 Avenue Tibbitts, Valencia, CA, 91355-3447

    Description

    Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.

    Reason

    The product has an incorrect reference value for cadmium and an incorrect expected range.

    Action

    The recalling firm issued a recall letter dated 3/19/2020 via email on 3/20/2020 requesting customers to destroy the incorrect IFU and replace it with the revised IFU.

    Distribution

    Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.

    Quantity

    1,395 vials