BEUDAMED
    FDA Enforcement Class II Terminated

    The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.

    Recall: Z-0948-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0948-2015
    Event ID
    69300
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Molecular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    November 23, 2013
    Classification Date
    January 9, 2015
    Termination Date
    December 4, 2017
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    Description

    The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.

    Reason

    The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.

    Code Info

    List Number: 09K14-02; Model: E-series; Serial Numbers: 10664 - 10833, 1004, 1005, 10142, 10154, 10171, 10416

    Distribution

    Worldwide Distribution - USA including CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, and TX and Internationally to Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Indonesia, Ireland, Israel, Italy, Kazakhstan, Kenya, Malawi, Mali, Mexico, Morocco, Mozambique, New Zealand, Nigeria, Norway, Pakistan, Poland, Russia, Saudi Arabia, Senegal, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.

    Quantity

    176 devices