BEUDAMED
    FDA Recall Terminated

    i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.

    Recall: Z-0912-05 · Initiated March 16, 2005

    Recall

    Recall Number
    Z-0912-05
    Event Number
    31502
    Firm
    Abbott Laboratories
    FEI Number
    2245578
    Product Code
    JBP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2005
    Posted
    June 21, 2005
    Terminated
    June 30, 2006
    Address
    104 Windsor Center Dr, East Windsor, NJ, 08520-1407

    Description

    i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.

    Reason

    Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.

    Action

    The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.

    Distribution

    The cartridges have been distributed to hospitals and clinics nationwide. The cartridges have been distributed to Austria, Australia, Canada, Switzerland, China, Colombia, Germany, France, Greece, Hong Kong, India, New Zealand, and Singapore. There are 15 VA hospitals identified. There are 3 government and military accounts.

    Quantity

    298006 cartridges