BEUDAMED
    FDA Recall Terminated

    Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.

    Recall: Z-0913-2013 · Initiated November 28, 2012

    Recall

    Recall Number
    Z-0913-2013
    Event Number
    64000
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 28, 2012
    Posted
    March 6, 2013
    Terminated
    February 24, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.

    Reason

    Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.

    Action

    Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Call Center Hotline at (800) 854-3633 for questions regarding the notice.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Malaysia, Netherlands, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United Kingdom, and Viet Nam.

    Quantity

    28 in U.S.; 4 Canada; 318 to other foreign countries.