BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    Recall: Z-1936-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1936-2019
    Event ID
    82784
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    April 8, 2019
    Classification Date
    July 3, 2019
    Termination Date
    November 12, 2020
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

    Reason

    Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

    Code Info

    All lots

    Distribution

    US Nationwide Distribution

    Quantity

    3889 units