BEUDAMED
    FDA Recall Open, Classified

    AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255

    Recall: Z-0492-2020 · Initiated November 9, 2018

    Recall

    Recall Number
    Z-0492-2020
    Event Number
    83732
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JQP
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    November 9, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255

    Reason

    Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) .

    Action

    A "Urgent Medical device Recall" letter was sent to affected consignees on November 9, 2018 via USPS. The letter informed consignees of the following: 1. If you are using the MTP kit option of the AutoMate 2500 Family systems, please ensure that your system meets the required software prerequisites stated in the Issue section. " If the requirements are met, you can safely continue using your system. " If the requirements are not met; Permanently discontinue using the MTP kit option or Contact your Beckman Coulter representative to upgrade your system to meet the required software prerequisites. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 3. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. 5. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. 6. If you have any questions regarding this notice, please contact Beckman Coulter via: http://www.beckmancoulter.com; by phone (800) 526-3821, or your local Beckman Coulter representative.

    Distribution

    US: NY, VA OUS: Austria Belgium Czech Republic France Germany Israel Italy Lithuania Mayotte Romania Slovakia South Africa Spain Sweden Switzerland United Kingdom

    Quantity

    83 automate systems