BEUDAMED
    FDA Recall Terminated

    Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]

    Recall: Z-1224-03 · Initiated July 28, 2003

    Recall

    Recall Number
    Z-1224-03
    Event Number
    27035
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2003
    Posted
    September 11, 2003
    Terminated
    November 24, 2003
    Address
    100 Indigo Creek Drive, Rochester, NY, 14650-0881

    Description

    Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]

    Reason

    Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.

    Action

    GLU Slides: Letters dated between 7/28/03 and 8/11/03 provide revised storage instructions. Customers using NaF/KOx blood collection tubes and have VITROS GLU slides that have been refrigerated for more than four months will receive replacement product. Those customers are instructed to continue to use the slides only until replacement product arrives. GLU DT Slides: Letters dated between 7/28/03 and 8/11/03 with the same instructions as for GLU slides.

    Distribution

    Nationwide and worldwide distribution to distributors and end-users.

    Quantity

    487,912 boxes