BEUDAMED
    FDA Recall Open, Classified

    remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

    Recall: Z-2531-2023 · Initiated August 14, 2023

    Recall

    Recall Number
    Z-2531-2023
    Event Number
    92880
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    JSD
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 14, 2023
    Posted
    September 8, 2023
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

    Reason

    On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

    Action

    ThermoFisher SCIENTIFIC disseminated a "Medical Device Field Action Recall" to its consignees on 08/14/2023 by US mail. The notice explained the problem, the risk to health, and requested the following actions be taken: - Destroy any remaining affected product in inventory; - A review of reported test results should be evaluated by an appropriate technical expert; - Pass the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred; - Keep the notice on file. The firm will replace the product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected].

    Distribution

    US Nationwide Distribution

    Quantity

    139 units (13,900 tests)