BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems

    Recall: Z-2202-2019 · Initiated June 17, 2019

    Recall

    Recall Number
    Z-2202-2019
    Event Number
    83228
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305840
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 17, 2019
    Terminated
    November 9, 2020
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601

    Description

    VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems

    Reason

    Potentially Biased Results using VITROS Chemistry Products GLU Slides

    Action

    Ortho issued On 17 June 2019, a customer letter (Ref. CL2019-172) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to customers and distributors. The customers were notified of the issue and instructed: Discontinue using Lot 0048-0964-9287, discard any remaining inventory and switch to an alternate lot. " If you do NOT have an alternate lot, consider the following alternate options: o Use an alternate glucose method until your replacement order arrives. o Consult with your medical director to determine if the bias observed and rate of occurrence when using the affected lot is acceptable for continued use, and if so, continue to use until your replacement arrives. " Ortho will credit and/or replace your remaining inventory of Lot 0048-0964-9287. Please specify full and/or partial sales units remaining and indicate your preference of credit or replacement on your Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than June 21, 2019. " Post this notification by each system that processes VITROS GLU Slides or with your user documentation until you switch to an alternate lot. " Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

    Distribution

    US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN

    Quantity

    1099 (5 pack x 60)=329700 slides