BEUDAMED
    FDA Enforcement Class II Terminated

    BS-200 Chemistry Analyzer Designed for clinical laboratory use.

    Recall: Z-0977-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0977-2013
    Event ID
    64112
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    November 28, 2012
    Classification Date
    March 22, 2013
    Termination Date
    June 12, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430, United States

    Description

    BS-200 Chemistry Analyzer Designed for clinical laboratory use.

    Reason

    An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

    Code Info

    Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.

    Distribution

    Distributed in the states of NC and TX.

    Quantity

    3 units