BEUDAMED
    FDA Enforcement Class II Ongoing

    SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

    Recall: Z-0441-2026 · Reported November 12, 2025

    Enforcement

    Recall Number
    Z-0441-2026
    Event ID
    97628
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2025
    Initiation Date
    September 17, 2025
    Classification Date
    November 6, 2025
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

    Reason

    Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

    Code Info

    REF: 969706. Lot: M404166. Expiration Date: 30Nov2025

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA, HI, IA, ID, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, PR, QC, SC, TX, WA, WV and the country of Canada.

    Quantity

    2,932 units