BEUDAMED
    FDA Enforcement Class II Terminated

    Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.

    Recall: Z-1255-2021 · Reported March 24, 2021

    Enforcement

    Recall Number
    Z-1255-2021
    Event ID
    87223
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    R & D Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 24, 2021
    Initiation Date
    January 20, 2021
    Classification Date
    March 15, 2021
    Termination Date
    February 13, 2023
    Address
    614 Mckinley Pl Ne, N/A, Minneapolis, MN, 55413-2610, United States

    Description

    Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.

    Reason

    R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.

    Code Info

    Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604

    Distribution

    USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,

    Quantity

    156 kits