BEUDAMED
    FDA Enforcement Class II Ongoing

    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

    Recall: Z-0399-2022 · Reported December 29, 2021

    Enforcement

    Recall Number
    Z-0399-2022
    Event ID
    89035
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 29, 2021
    Initiation Date
    November 10, 2021
    Classification Date
    December 20, 2021
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

    Reason

    Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.

    Code Info

    Lot: M106450, UDI: 15099590575113

    Distribution

    US Nationwide distribution in the states of Louisiana, Ohio, North Carolina, California, South Carolina, Oklahoma, Pennsylvania, New York, Florida, New Jersey, Wisconsin, Alabama, Texas, Georgia, Maine, North Dakota, Virginia, Kansas, Washington, New Mexico, Iowa ,Nebraska, Idaho, Michigan, Maryland, Arizona, Hawaii, Missouri, Oregon, Mississippi, Rhode Island, Alaska, Tennessee, Illinois, Delaware, Kentucky, Arkansas, West Virginia, Massachusetts. OUS: India, South Africa, Saudi Arabia, Canada, Lebanon, Singapore, Philippines, Thailand

    Quantity

    1433