BEUDAMED
    FDA Recall Terminated

    Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.

    Recall: Z-0046-2018 · Initiated August 3, 2017

    Recall

    Recall Number
    Z-0046-2018
    Event Number
    77982
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 3, 2017
    Terminated
    September 27, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.

    Reason

    Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should not occur. This issue and associated complaint were discovered and filed internally.

    Action

    BEC will initiate a SW update- to fix the SW defect. This will be executed via MOD (field modification) performed by Field Service.

    Distribution

    China France Italy Kuwait Spain Turkey United States

    Quantity

    27 units