BEUDAMED
    FDA Enforcement Class II Terminated

    BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558

    Recall: Z-1377-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1377-2021
    Event ID
    87546
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 14, 2021
    Initiation Date
    March 17, 2021
    Classification Date
    April 8, 2021
    Termination Date
    August 5, 2022
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558

    Reason

    Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment

    Code Info

    Lot Numbers: 0317559 Exp. Date 2021-MAR-11; 0345695 Exp. Date 2021-APR-06 UDI: 01)30382902215586 (10)0317559(17)031121 (30)0100 (01)30382902215586 (10)0345695(17)040621 (30)0100

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.

    Quantity

    15550 EA