BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0441-2026 · Initiated September 17, 2025

    Recall

    Recall Number
    Z-0441-2026
    Event Number
    97628
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    MRR
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 17, 2025
    Posted
    November 6, 2025
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    Action

    Beckman Coulter notified consignees via letter on about 09/17/2025. Consignees were instructed to discontinue use of SYNCHRON Systems LDLD reagent lot M404166 and contact Customer Technical Support Center for assistance, review the Safety Data Sheet (SDS) and discard according to laboratory s Standard Operating Procedures and/or your local regulations. The SDS is available at www.beckmancoulter.com. Additionally, Beckman Coulter recommends sharing the content of this letter with laboratory and/or medical director regarding the need to perform a retrospective review of the patient results generated from the SYNCHRON Systems LDLD reagent lot M404166 to determine if retesting is necessary.

    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