BEUDAMED
    FDA Enforcement Class II Ongoing

    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

    Recall: Z-0997-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0997-2026
    Event ID
    97842
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Ireland, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2025
    Initiation Date
    October 14, 2025
    Classification Date
    December 23, 2025
    Address
    Lismeehan, N/A, O'Callaghan'S Mills, N/A, N/A, Ireland

    Description

    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

    Reason

    Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

    Code Info

    Catalog Numbers / UDI-DI codes: OSR6137 - 15099590020187 Lot Numbers: 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2693 2694 2695 2696 OSR6237 - 15099590010348 Lot Numbers: 2702 2703 2704 2705 2706 2707 2708 2709 2710 2712 2713 2714 2715 2716 OSR6637 - 15099590060206 Lot Numbers: 2726 2728 2729 2730 2731 2732 2733 2734 2736 2737 2738 2739

    Distribution

    Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guan, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Brazil, Canada, Ecuador, Ireland, Mexico, Netherlands, Panama, Taiwan, and Province of China.

    Quantity

    36,981 reagents (U.S.-35,320, O.U.S.-1,661)