BEUDAMED
    FDA Recall Terminated

    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

    Recall: Z-2598-2018 · Initiated May 16, 2018

    Recall

    Recall Number
    Z-2598-2018
    Event Number
    80388
    Firm
    Becton, Dickinson and Company, BD Biosciences
    FEI Number
    2916837
    Product Code
    OYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 16, 2018
    Posted
    July 13, 2018
    Terminated
    August 13, 2018
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and 40-tube racks. A barcode reader verifies the ID on tube racks and individual tubes in 30- tube racks. A built-in imaging system provides safety checks, such as verifying the correct rack type and tube layout, and ensures the tubes were loaded correctly.

    Reason

    The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

    Action

    The firm, BD Life Sciences, produced the "URGENT PRODUCT RECALL-CORRECTION" letter dated 4/6/2018 to its customers during an on-site visit. by the field service engineer made beginning 5/16/2018 to correct the issue. The visits were completed 6/15/2018. If you require further assistance, contact BD Customer/Technical Support BD Customer Support at 877.232.8995 (prompt 2) for instruments in the United States. For customers outside the US, contact your local BD representative or distributor.

    Distribution

    US Distribution was made to FL, KS, KY, MA, NJ, and SD.

    Quantity

    8 devices