BEUDAMED
    FDA Recall Terminated

    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.

    Recall: Z-2145-2016 · Initiated May 9, 2016

    Recall

    Recall Number
    Z-2145-2016
    Event Number
    74346
    Firm
    ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom
    FEI Number
    3007111389
    Product Code
    LOJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 9, 2016
    Terminated
    June 8, 2018

    Description

    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.

    Reason

    Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.

    Action

    The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Customer Letter (Ref. CL2016-098) dated 5/9/2016, via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected product. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue distributing and discard the affected lots; complete and return the Confirmation of Receipt form by May 18, 2016 via Fax to 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: [email protected], and forward this notification if you have distributed these systems outside of your facility. If you have any questions, contact Customer Technical Services at 1-800-421-3311.

    Distribution

    US Nationwide Distribution

    Quantity

    US: Lot 6471 - 282, Lot 6480 - 344