BEUDAMED
    FDA Enforcement Class II Terminated

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    Recall: Z-0252-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0252-2013
    Event ID
    63270
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 14, 2012
    Initiation Date
    June 15, 2012
    Classification Date
    November 6, 2012
    Termination Date
    July 19, 2013
    Address
    5 Century Dr, N/A, Parsippany, NJ, 07054-4607, United States

    Description

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    Reason

    Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.

    Code Info

    K082248 D089976 Ref 58104 units

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada

    Quantity

    232 units US; 5 units Canada