BEUDAMED
    FDA Recall Terminated

    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

    Recall: Z-1834-2020 · Initiated March 10, 2020

    Recall

    Recall Number
    Z-1834-2020
    Event Number
    85298
    Firm
    Ortho Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    KLI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 10, 2020
    Terminated
    September 26, 2022
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

    Reason

    The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

    Action

    IMPORTANT PRODUCT CORRECTION NOTIFICATION letters dated 3/10/20 were sent to customers. REQUIRED ACTIONS " If you have VITROS TT4 Reagent Packs Lot 2340 in your inventory, Ortho will replace or credit your account as indicated on your Confirmation of Receipt form. NOTE: As a reminder, if you have a successful calibration, and quality control results are acceptable, it is acceptable to continue using the affected lot. " Post this notification by each system that processes VITROS TT4 Reagent Packs, Lot 2340. " Complete the Confirmation of Receipt form now to register receipt of the notification. All customers should return the completed form by March 25, 2020. " If you are satisfied with the product at this time but want Lot 2340 replaced in the future, you may resubmit the Confirmation of Receipt form at that time, indicating the quantity that requires replacement. " In the event of future occurrences, retain a copy of the Confirmation of Receipt form and re-submit if needed. " Please forward this notification if the product was distributed outside of your facility. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

    Distribution

    US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.

    Quantity

    3181