BEUDAMED
    FDA Enforcement Class II Terminated

    i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.

    Recall: Z-2361-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2361-2015
    Event ID
    71665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2015
    Initiation Date
    June 15, 2015
    Classification Date
    August 10, 2015
    Termination Date
    February 19, 2016
    Address
    400 College Rd E, N/A, Princeton, NJ, 08540-6607, United States

    Description

    i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.

    Reason

    Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.

    Code Info

    All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.

    Quantity

    423,168 cartridges