BEUDAMED
    FDA Recall Terminated

    VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest

    Recall: Z-1364-2019 · Initiated March 20, 2019

    Recall

    Recall Number
    Z-1364-2019
    Event Number
    82561
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 20, 2019
    Terminated
    December 8, 2020
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest

    Reason

    Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported

    Action

    Ortho Clinical Diagnostics issued on 20 March 2019, a customer letter via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) customers who were shipped affected VITROS XT 7600 Systems. Software Version 3.4.2 (MOD 4) will be provided for download or DVD format. Contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines

    Quantity

    85 units: US=19;OUS=66