BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.

    Recall: Z-0848-2019 · Initiated December 11, 2018

    Recall

    Recall Number
    Z-0848-2019
    Event Number
    81806
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305841
    Product Code
    LEG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 11, 2018
    Terminated
    September 16, 2020
    Address
    1000 Lee Road, Rochester, NY, 14606

    Description

    VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.

    Reason

    Negative bias results when using VITROS VALP Reagent, GEN 25.

    Action

    The firm, Ortho Clinical Diagnostics, issued on 11 December 2018, a "URGENT PRODUCT CORRECTION NOTIFICATION" customer letter (Ref. CL2018-267) sent 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 were shipped VITROS Chemistry Products VALP GEN 25. Foreign affiliates were informed by email on 11 December 2018 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. The customers were notified of the issue and instructed to cease use of VALP GEN 25. If you have any GEN 25 (Lot 25-6393) remaining in your inventory, Ortho will provide replacement or credit your account. " Discontinue using Gen 25 (Lot 25-6393), discard any remaining inventory, and switch to GEN 26 or above. " If you do NOT have GEN 26 or above at this time, consider the following alternate options: o Use an alternate valproic acid method until your replacement order arrives. o Consult with your medical director to determine if the bias observed when using GEN 25 is acceptable for continued use, and if so, continue to use until your replacement arrive. In accordance with regulatory requirements, complete and return the Confirmation of Receipt - Response form no later than December 19, 2018 via Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: RA-OCDUS [email protected]. " Post this notification by your VITROS System or with your user documentation. " Forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311..

    Distribution

    Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom.

    Quantity

    9014 Total (U.S. = 6798; OUS: U.S. = 2216)