BEUDAMED
    FDA Enforcement Class III 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 · Reported July 1, 2020

    Enforcement

    Recall Number
    Z-2407-2020
    Event ID
    85660
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Utak Laboratories Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2020
    Initiation Date
    March 20, 2020
    Classification Date
    June 22, 2020
    Termination Date
    July 22, 2020
    Address
    25020 Avenue Tibbitts, N/A, Valencia, CA, 91355-3447, United States

    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.

    Code Info

    Lot C2540

    Distribution

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

    Quantity

    1,395 vials