BEUDAMED
    FDA Recall Terminated

    Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.

    Recall: Z-0623-2011 · Initiated August 25, 2010

    Recall

    Recall Number
    Z-0623-2011
    Event Number
    56679
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 25, 2010
    Posted
    December 16, 2010
    Terminated
    May 15, 2012
    Address
    4238 Capital Dr, Monroe, NC, 28110

    Description

    Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.

    Reason

    Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results.

    Action

    Greiner Bio-One instructed customers to stop distribution and to complete an attached Product Disposition form and return it via fax to Greiner Bio-One. They were further instructed to destroy any product they may have. Distributors were instructed provide a list of their customers that have received the affected item via Excel file so that they can be notified of the recall.

    Distribution

    Nationwide Distribution: USA, including the states of CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI.

    Quantity

    18 cases (total 21,600 pieces)