BEUDAMED
    FDA Recall Terminated

    VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia

    Recall: Z-0392-2019 · Initiated August 28, 2018

    Recall

    Recall Number
    Z-0392-2019
    Event Number
    81066
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    CDD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 28, 2018
    Terminated
    August 11, 2020
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia

    Reason

    The reagent pack exhibits the potential for an increased frequency of calibration failures.

    Action

    The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated 8/28/18 to customers. A second "IMPORTANT UPDATE: PRODUCT CORRECTION NOTIFICATION" letter dated 10/22/18 was distributed to customers to inform them of additional affected lots. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: If this lot was successfully calibrated and your quality control results are acceptable; you may continue using your existing inventory of VITROS Vitamin B12 Reagent Pack 1/2 Lot 2601 until your replacement order arrives. We advise that you perform quality control on every reagent pack. " If this lot cannot be successfully calibrated, contact our Ortho Care" Technical Solutions Center. " Complete the Confirmation of Receipt Response Required form and return by September 12, 2018 (so that we can credit your account or expedite your replacement order) via Fax: to: 1.888.557.3759 or 1.585.453.4110 or e-Mail to: [email protected]. " Discontinue using Lot 2601 upon receipt of your replacement order. " Post this notification by each system that processes VITROS Vitamin B12 Reagent Pack 1/2. " Forward this notification if the product was distributed outside of your facility The distributors were instructed to do the following: Discontinue distributing and discard all inventory of VITROS Vitamin B12 Reagent Pack 1/2 and Calibrators for Lot 2610 and/or 2620. " Send the customer letter to all customers who were shipped VITROS Vitamin B12 Reagent, Lots 2610 and/or 2620 from your facility. " Complete and return the Confirmation of Receipt form no later than November 5, 2018. " Forward this notification if you have distributed this product outside of your facility. If you have further questions, please contact our Ortho Care" Technical Solutions Center at 1-800-421-3311.

    Distribution

    Worldwide Distribution: US (nationwide) to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VT, WA, WI, WV, and WY; and countries of: Belgium, Bermuda, Brazil, Canada, Chile, Columbia, Denmark, France, Germany, India, Italy, Portugal, Spain, and UK.

    Quantity

    6630