BEUDAMED
    FDA Recall Terminated

    Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    Recall: Z-0075-2007 · Initiated September 18, 2006

    Recall

    Recall Number
    Z-0075-2007
    Event Number
    36436
    Firm
    Stanbio Laboratory, Inc
    FEI Number
    1616487
    Product Code
    LBR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 18, 2006
    Posted
    November 14, 2006
    Terminated
    June 6, 2007
    Address
    1261 N Main St, Boerne, TX, 78006-3014

    Description

    Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    Reason

    Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

    Action

    Firm notified consignees via letter on 09/20/06.

    Distribution

    Worldwide, including USA, Korea, Thailand, Venezuela and Mexico.

    Quantity

    05276CE: 78 test kits; 05312CE: 6 test kits; 05299CE: 10 test kits.