BEUDAMED
    FDA Enforcement Class III Ongoing

    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095

    Recall: Z-1390-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1390-2022
    Event ID
    90445
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    R & D Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 27, 2022
    Initiation Date
    June 14, 2022
    Classification Date
    July 15, 2022
    Address
    614 Mckinley Pl Ne, N/A, Minneapolis, MN, 55413-2610, United States

    Description

    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095

    Reason

    The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body designation, British Standards Institution number 2797 (BSI-2797) for product inserts 750095.28 and 750095.29. The erroneous label CE2797 were in the IFU insert revision 750095.28 for the 408 affected lots that were shipped. No product was packed with erroneous insert revision 750095.29. Since the product is currently CE marked as a Class I - self-certified product under the EU In Vitro Diagnostics Directive, the Notified Body designation should not be specified. As part of the corrective action, the firm has notified the customers who received the products with erroneous labeling, and is conducting the replacements with the correct product insert containing the Insert Revision 750095.30

    Code Info

    Lot Code: UDI 00815762021671, Lot Codes: P301801; P304262; P306132; P310038; P314685; P320216; P322531 Expiration Date: 08/04/2023

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, MN, UT, OH, MA, TX, PR, PA, NJ, CA, WI, LA, Puerto Rico, and the countries of CANADA, UNITED KINGDOM, ISRAEL, MEXICO, THAILAND, CHINA, HONG KONG, AUSTRALIA, INDONESIA.

    Quantity

    400