BEUDAMED
    FDA Recall Terminated

    1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

    Recall: Z-1700-2016 · Initiated February 18, 2016

    Recall

    Recall Number
    Z-1700-2016
    Event Number
    73441
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    DHA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 18, 2016
    Terminated
    May 30, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

    Reason

    When testing was conducted using certain lots, VITROS Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).

    Action

    On February 18, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification letters and Confirmation of Receipt Forms to their customers (Ref. CL2016-043) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to immediately discontinue using and discard all remaining inventory of the listed lots. Ortho Clinical Diagnostics will replace all remaining inventory or provide account credits as indicated on the confirmation of receipt form. Customers are advised to review previously reported results using the affected lots and to discuss these findings with your Laboratory Medical Director to determine the appropriate course of action. Post the notification by your VITROS System or with your user documentation. Complete and return the Confirmation of Receipt form to Joe Falvo via email at [email protected] or by fax to 1-888-557-3759 or to 1-585-453-4110. Clients with questions can contact Customer Technical Services at 1-800-421-3311 at any time.

    Distribution

    Nationwide Distribution.

    Quantity

    14,780 pieces