BEUDAMED
    FDA Recall Terminated

    Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.

    Recall: Z-0691-2019 · Initiated November 1, 2018

    Recall

    Recall Number
    Z-0691-2019
    Event Number
    81550
    Firm
    R & D Systems, Inc.
    FEI Number
    2182501
    Product Code
    JNM
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 1, 2018
    Terminated
    November 3, 2020
    Address
    614 McKinley Pl NE, Minneapolis, MN, 55413-2610

    Description

    Quantikine IVD ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.

    Reason

    The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.

    Action

    R&D Systems, Inc. notified partners on about 11/01/2018 via email. Instructions to Partners included to quarantine and destroy all affected kits on hand, complete and return the Medical Device Recall Return Response form by 11/19/2018, and update and send to customers if further distributed the provided customer letter and Partner Medical Device Recall Return Response form. Both must be sent to each affected partner's customer. Add customer-specific information to the editable Partner Customer Medical Device Recall Return form (replace highlighted text) and include your office email. On your Company stationary, prepare a cover letter for this (1) Recall Notification Customer Letter and (2) partner customer Medical Device Recall Return Response form. Should you mail a hard copy of the letter and Medical Device Recall Return Response Form, address the return envelopes to your office. Additionally partners were instructed to follow up to ensure each affected customer returns a response form, and send all completed returned response form to [email protected].

    Distribution

    US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.

    Quantity

    198 kits