BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0463-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0463-2015
    Event ID
    69542
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Molecular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    October 23, 2014
    Classification Date
    November 25, 2014
    Termination Date
    March 8, 2016
    Address
    1300 E Touhy Ave, N/A, Des Plaines, IL, 60018-3315, United States

    Description

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

    Reason

    Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.

    Code Info

    List Number: 09K14; Models: E series, G series

    Distribution

    Worldwide distribution. US nationwide (CA, CT, FL, NC, PA, SC, and DC), Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Colombia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , Vietnam

    Quantity

    9 CD ROMs (US); 1,273 CD ROMs (Foreign)