BEUDAMED
    FDA Enforcement Class II Terminated

    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.

    Recall: Z-0634-2013 · Reported January 9, 2013

    Enforcement

    Recall Number
    Z-0634-2013
    Event ID
    63746
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Molecular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 9, 2013
    Initiation Date
    December 4, 2012
    Classification Date
    January 3, 2013
    Termination Date
    March 8, 2016
    Address
    1300 E Touhy Ave, N/A, Des Plaines, IL, 60018-3315, United States

    Description

    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.

    Reason

    An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.

    Code Info

    list 09K14, all serial numbers and all software versions 1.0 - 5.0

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Burkina Faso, Burundi, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ethiopia, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mexico, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam and Zambia

    Quantity

    215 units - U.S., 693 units - ROW