BEUDAMED
    FDA Recall Terminated

    Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.

    Recall: Z-0919-03 · Initiated March 26, 2003

    Recall

    Recall Number
    Z-0919-03
    Event Number
    26148
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    CEK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 26, 2003
    Posted
    June 5, 2003
    Terminated
    November 16, 2004
    Address
    100 Indigo Creek Drive, Rochester, NY, 14650-0881

    Description

    Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.

    Reason

    Slides may exhibit random, elevated imprecision of results.

    Action

    Notification via letter dated 3/26/03 with instructions to discard product.

    Distribution

    Nationwide and Worldwide.

    Quantity

    29,273 (domestic); 4,967 (international)