BEUDAMED
    FDA Enforcement Class II Terminated

    TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

    Recall: Z-1796-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1796-2013
    Event ID
    65635
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Haemonetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    June 20, 2013
    Classification Date
    July 24, 2013
    Termination Date
    June 4, 2015
    Address
    400 Wood Road, N/A, Braintree, MA, 02184-2412, United States

    Description

    TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

    Reason

    Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

    Code Info

    Per recall strategy.

    Distribution

    US Nationwide

    Quantity

    1590 devices