BEUDAMED
    FDA Recall 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 · Initiated December 4, 2012

    Recall

    Recall Number
    Z-0634-2013
    Event Number
    63746
    Firm
    Abbott Molecular
    FEI Number
    3005248192
    Product Code
    JJH
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 4, 2012
    Posted
    January 3, 2013
    Terminated
    March 8, 2016
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    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.

    Action

    Abbott Molecular Inc. sent a Field Correction Recall/Urgent Field Safety Notice letter dated December 4, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to follow the instructions identified until an upgrade to their m2000sp software can be installed. Abbott Molecular estimates that this software version will be available the first quarter of 2013. They were requested to complete the enclosed reply sheet and fax it to (847) 775-6728 at prior to December 18, 2012 to acknowledge receipt and understanding of the letter. For questions customers were instructed to contact their local Abbott Molecular representative. For questions regarding this recall call 224-361-7274.

    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