BEUDAMED
    FDA Recall Open, Classified

    Apo B Reagent, REF: OSR6143

    Recall: Z-1815-2025 · Initiated April 23, 2025

    Recall

    Recall Number
    Z-1815-2025
    Event Number
    96746
    Firm
    Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland
    FEI Number
    1000206808
    Product Code
    JHN
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    April 23, 2025
    Posted
    May 23, 2025

    Description

    Apo B Reagent, REF: OSR6143

    Reason

    The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.

    Action

    On April 23, 2025, Beckman Coulter issued a "Urgent Medical Device Recall" Notification to affected consignees via mail and E-Mail. Beckman Coulter asked consignees to take the following actions: 1. If your laboratory is reporting Apo B results generated using the combination of reagent OSR6143, Lot 2631 and calibrator ODR3022, Lot 3000 in mg/dL units, a retrospective review of patient results greater than 77 mg/dL and less than 176 mg/dL is recommended. 2. Discard the value assignment sheet located within each kit of Apo B OSR6143 Lot 2631. 3 Download the updated VAS kit insert from the Beckman Coulter website by searching LOSR6143_2631_ML.02. Beckman Coulter Diagnostics | Beckman Coulter. 4. Ensure that the level 4 calibrator ODR3022, Lot 3000 target value used for calibration of Apo B OSR6143 Lot 2631 is 116 mg/dL and aligns with the corrected VAS. 5. Please 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(s) listed above to another laboratory, please provide them a copy of this letter.

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MD, MI, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV and the countries of Argentina, Australia, Belarus, Belgium, Bulgaria, Canada, China, Czechia, Egypt, Estonia, France, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam.

    Quantity

    2747 units