BEUDAMED
    FDA Recall Terminated

    i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.

    Recall: Z-0180-2012 · Initiated September 29, 2011

    Recall

    Recall Number
    Z-0180-2012
    Event Number
    60048
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 29, 2011
    Posted
    November 10, 2011
    Terminated
    March 11, 2013
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-Stat cTnI cartridges Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.

    Reason

    i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results.

    Action

    APOC issued Urgent Recall Notices/Business Reply Forms dated September 2011 to consignees. The letter identified the affected product and explained the background of the problem. Customers are to discontinue use of the cartridges from the lots identified. All unused product will be credited and should be returned as instructed on the attached Business Reply Card. If the affected product was further distributed, a copy of the Recall Notice should be provided to those customers as well. APOC shipped replacement product in order to minimize any disruption. If replacement product has not been received then customers should contact Customer Service at 1-800-366-8020, option 5. Questions regarding this information should be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1 or customers' local APOC representative.

    Distribution

    Worldwide Distribution

    Quantity

    1,688,755 cartridges