BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

    Recall: Z-1179-2017 · Initiated December 8, 2016

    Recall

    Recall Number
    Z-1179-2017
    Event Number
    75936
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305840
    Product Code
    JGP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 8, 2016
    Terminated
    June 22, 2018
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601

    Description

    VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.

    Reason

    There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.

    Action

    On December 8, 2016, Ortho Clinical Diagnostics distributed Product Correction Notification letters to their customers via FedEx, ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to check their stock for affected product and to immediately discontinue and discard all remaining inventory. Ortho will credit your account for any discarded VITROS UPRO Slides, VITROS Chemistry Products Calibrator Kit 10 and/or VITROS Chemistry Products UPRO Performance Verifier I & II. Please complete the Confirmation of Receipt and return by December 22, 2016. Customers with questions, please contact Ortho CareTM Technical Solutions Center at 1-800-421-3311.

    Distribution

    Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.

    Quantity

    37,571 packs/90 slides totalling 3,381,390 slides