BEUDAMED
    FDA Recall Open, Classified

    VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

    Recall: Z-0503-2022 · Initiated November 22, 2021

    Recall

    Recall Number
    Z-0503-2022
    Event Number
    89183
    Firm
    Ortho-Clinical Diagnostics, Inc.
    FEI Number
    1000136573
    Product Code
    PPM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 22, 2021
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

    Reason

    Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.

    Action

    Ortho clinical Diagnostics issued an Important product correction notification on November 22, 2021. Actions to be taken by the Distributors: 1. Please provide the communication (Ref. CL2021-287) to customers who were shipped VITROS HSDA Lot 2190 from your facility. 2. Do not continue to distribute VITROS HSDA Lot 2190. 3. Complete the Confirmation of Receipt form no later than November 30, 2021. 4. Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact our Ortho Care" Technical Solutions Center at 1-800-421-3311. Action to be taken by the customers: 1. Discontinue using VITROS HSDA Lot 2190 if your laboratory utilizes VITROS TSH Reagent Pack. 2.Complete the Confirmation of Receipt form no later than November 30, 2021, even if no replacement product is required. If replacement is required, indicate the quantity of VITROS HSDA Lot 2190 to be replaced. 3. Please forward this notification if the product was distributed outside of your facility. Contact Information If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.

    Quantity

    1416 units