BEUDAMED
    FDA Recall Terminated

    VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immuno rate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

    Recall: Z-1469-2012 · Initiated March 15, 2012

    Recall

    Recall Number
    Z-1469-2012
    Event Number
    61409
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305841
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 15, 2012
    Posted
    April 26, 2012
    Terminated
    September 20, 2017
    Address
    1000 Lee Road, Rochester, NY, 14606

    Description

    VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immuno rate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

    Reason

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.

    Action

    Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.

    Distribution

    Worldwide Distribution

    Quantity

    50