BEUDAMED
    FDA Enforcement Class III Terminated

    AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.

    Recall: Z-1040-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1040-2017
    Event ID
    76054
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    January 25, 2017
    Initiation Date
    December 21, 2016
    Classification Date
    January 18, 2017
    Termination Date
    May 17, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    Description

    AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.

    Reason

    Beckman Coulter initiated a design change to update the Automate PC image to accommodate the operating system change to Windows 10.

    Code Info

    ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438

    Distribution

    US Distribution to MD only.

    Quantity

    4 units