BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0463-2015 · Initiated October 23, 2014

    Recall

    Recall Number
    Z-0463-2015
    Event Number
    69542
    Firm
    Abbott Molecular
    FEI Number
    3005248192
    Product Code
    JJH
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    October 23, 2014
    Posted
    November 25, 2014
    Terminated
    March 8, 2016
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    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.

    Action

    Field Correction Recall / Urgent Field Safety Notice letters dated September 23, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) review the app spec files that are installed on the m2000sp system and delete any incompatible app specs; 2) if one or more app spec files were deleted, installation of new app spec file(s) is needed; and, 3) review this information with laboratory personnel and retain the letter for future reference. Customers with questions about this market action can contact Technical Support at 800-553-7042, Option 2, or the local Abbott Molecular representative.

    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)