BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count) --- indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems.

    Recall: Z-1316-2012 · Initiated February 2, 2012

    Recall

    Recall Number
    Z-1316-2012
    Event Number
    61222
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    LBS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 2, 2012
    Posted
    March 26, 2012
    Terminated
    July 5, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count) --- indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems.

    Reason

    Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type.

    Action

    Ortho Clinical Diagnostics sent an Important Product Information letter dated February 2, 2012, to all affected customers via Federal Express overnight mail. The letter informed customers of the issue, notifying them of the removal of EDTA plasma as a recommended sample type and providing the revised VITROS dHDL Slides Instructions for Use. J&J Foreign affiliate consignees were notified by email informing them of the issue on 02 February 2012. Customers were instructed to replace the current pages in their VITROS Chemistry Products Instructions for Use Manual with the updated instructions for Use and Table of Contents. Customers were asked to return the enclosed Confirmation of Receipt form regardless of whether their laboratory uses the affected product. For any questions regarding this recall call 1-800-421-3311.

    Distribution

    Worldwide Distribution

    Quantity

    120,225 of 60-slide count, 11.364 of 18-slide count