BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0046-2018 · Reported November 1, 2017

    Enforcement

    Recall Number
    Z-0046-2018
    Event ID
    77982
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    November 1, 2017
    Initiation Date
    August 3, 2017
    Classification Date
    October 24, 2017
    Termination Date
    September 27, 2023
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    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.

    Code Info

    Software version PLC V26R10

    Distribution

    China France Italy Kuwait Spain Turkey United States

    Quantity

    27 units