BEUDAMED
    FDA Recall Terminated

    Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.

    Recall: Z-0716-2013 · Initiated November 1, 2012

    Recall

    Recall Number
    Z-0716-2013
    Event Number
    64043
    Firm
    Abbott Point of Care Canada Limited
    FEI Number
    3005643513
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    November 1, 2012
    Posted
    January 24, 2013
    Terminated
    June 14, 2013
    Address
    185 Corkstown Road, Nepean Canada

    Description

    Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.

    Reason

    APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.

    Action

    APOC sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Abbott Point Of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point Of Care representative for questions regarding this information.

    Distribution

    Worldwide Distribution.

    Quantity

    560 boxes (25 cartridges in each box)