BEUDAMED
    FDA Recall Terminated

    VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413

    Recall: Z-0079-2019 · Initiated August 15, 2018

    Recall

    Recall Number
    Z-0079-2019
    Event Number
    80959
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 15, 2018
    Terminated
    January 10, 2022
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413

    Reason

    Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

    Action

    ORTHO PLUSSM is e-Communications, a service that provides subscribing customers with Ortho Clinical Diagnostics (Ortho) product notifications electronically on 15 August 2018, a customer letter (Ref. CL2018-174) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS 5600 Integrated Systems to inform them of the potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. Ortho also provided specific actions for customers to take when they observe unexpected MicroSlide assay results for a sample associated with TE1-504 and/or TE1-594 condition codes. Customers were also instructed to discuss any concerns related to this issue and previously reported results with the Laboratory Medical Director.

    Distribution

    Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain

    Quantity

    U.S.= 1255 ex-U.S.= 1504