BEUDAMED
    FDA Recall Terminated

    Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.

    Recall: Z-0958-2013 · Initiated December 28, 2012

    Recall

    Recall Number
    Z-0958-2013
    Event Number
    64162
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CGX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 28, 2012
    Posted
    March 15, 2013
    Terminated
    October 17, 2013
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.

    Reason

    Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.

    Action

    Beckman Coulter sent an Urgent Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed the customers that Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance. Customers are instructed to complete and return the enclosed response form. Customers with questions about the notification letter are instructed to contact the call center (hotline) at (800) 854-3633 in the US and Canada.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.

    Quantity

    57,962 units (50,452 units in the US)