BEUDAMED
    FDA Recall Terminated

    Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.

    Recall: Z-0814-2010 · Initiated August 18, 2009

    Recall

    Recall Number
    Z-0814-2010
    Event Number
    52754
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    JBP
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 18, 2009
    Posted
    February 23, 2010
    Terminated
    May 18, 2010
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.

    Reason

    Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.

    Action

    Abbott Point of Care issued an "Important Product Information" letter beginning August 18, 2009. Consignees were instructed on how to reconcile all affected product. For further information, contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1.

    Distribution

    Worldwide distribution.

    Quantity

    1,110,775 Cartridges