BEUDAMED
    FDA Recall Open, Classified

    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

    Recall: Z-2225-2023 · Initiated May 18, 2023

    Recall

    Recall Number
    Z-2225-2023
    Event Number
    92485
    Firm
    Ortho-Clinical Diagnostics, Inc.
    FEI Number
    1000136573
    Product Code
    JJX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 18, 2023
    Posted
    July 21, 2023
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

    Reason

    May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

    Action

    Ortho Clinical Diagnostics, Inc. (QuidelOrtho) issued Important Product Correction Notification letter on 5/18/23 via FedEx.. Letter states reason for recall, health risk and action to take: Discontinue using and discard your remaining inventory of VITROS NT-proBNP II Range Verifiers, Lot 0090. Ortho Clinical Diagnostics, Inc. will replace or credit your account. Indicate quantities to be replaced or credited via the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than May 26, 2023. " Please forward this notification if the affected product was distributed outside of your facility. " Save this notification with your user documentation or post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System until the issue has been resolved. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information: Ortho Care Technical Solutions Center at 1-800-421-3311.

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    2 units