BEUDAMED
    FDA Recall Terminated

    ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762

    Recall: Z-0042-2008 · Initiated September 20, 2007

    Recall

    Recall Number
    Z-0042-2008
    Event Number
    44909
    Firm
    Esa Biosciences, Inc.
    FEI Number
    1218996
    Product Code
    DOF
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 20, 2007
    Posted
    October 18, 2007
    Terminated
    March 25, 2008
    Address
    22 Alpha Rd, Chelmsford, MA, 01824-4123

    Description

    ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762

    Reason

    Level 1 and Level 2 Control values were incorrectly assigned.

    Action

    ESA notifed Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Vial label for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.

    Distribution

    Nationwide and United Kingdom.

    Quantity

    365 kits