BEUDAMED
    FDA Recall Open, Classified

    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

    Recall: Z-0399-2022 · Initiated November 10, 2021

    Recall

    Recall Number
    Z-0399-2022
    Event Number
    89035
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CHH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 10, 2021
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    Action

    On 11/10/21 recall notices were sent to customers. Customers with questions are encouraged to contact the Customer Support Center: http://www.beckmancoulter.com, 1-800-854-3633 in the United States and Canada. Customers were asked to take the following action: 1) Discontinue use of affected cholesterol reagent and follow the product replacement instructions. 2) Review the Safety Data Sheet (SDS) and discard according to your laboratory s Standard Operating Procedures and/or your local regulations. 3) Retrospective review is left to the discretion of the Laboratory Director. 4) Share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 5) Complete and return the Response Form. For customers in the United States, if you need replacement product, complete the Replacement Order Form.

    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