BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2531-2023
    Event ID
    92880
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remel, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2023
    Initiation Date
    August 14, 2023
    Classification Date
    September 8, 2023
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States

    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

    Code Info

    UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024

    Distribution

    US Nationwide Distribution

    Quantity

    139 units (13,900 tests)