BEUDAMED
    FDA Recall Open, Classified

    Access 2 Immunoassay Analyzer, Catalog Number 81600N

    Recall: Z-1386-2025 · Initiated February 5, 2025

    Recall

    Recall Number
    Z-1386-2025
    Event Number
    96248
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 5, 2025
    Posted
    March 17, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    Description

    Access 2 Immunoassay Analyzer, Catalog Number 81600N

    Reason

    Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.

    Action

    An URGENT MEDICAL DEVICE RECALL notification letter dated 1/31/25 was sent to customers. If the error occurs: 1. Confirm the system is in the Ready or Not Ready mode. 2. Go to the Initialize System window. To get to this window from the Main Menu, select Diagnostics F7 to display the Diagnostics menu, then select Initialize System F1. The Initialize System window is displayed with a confirmation message. 3. Select Yes F1 to initialize the instrument. Contact your Beckman Coulter representative if your laboratory has experienced sample carousel motion errors that are not resolved by initializing the analyzer. Your Beckman Coulter service representative will replace the sample motor during your next semi-annual preventative maintenance or repair visit. 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 listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support: From our website: http://www.beckmancoulter.com

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    873 units