BEUDAMED
    FDA Enforcement Class II Ongoing

    BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿

    Recall: Z-1039-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-1039-2024
    Event ID
    93789
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    January 8, 2024
    Classification Date
    February 8, 2024
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212, United States

    Description

    BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿

    Reason

    There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

    Code Info

    Catalog No. 231536 UDI-DI 00382902315360 Lots 1060689 1116935 1210905 1242939 1306103 1334461 2004540 2025116 2056456 2108378 2146453 2301307 3003869 3062089 3094151 3118079 3152968 3248444 0309595 0343394; Catalog No. 231539¿ UDI-DI 30382902315392 Lots 2339393 3003869 3062089 3094151 3118079 3152968 3214768 3248444 3282335 0309595 0343394 1060689 1116935 1148543 1210905 1242939 1306103 1334461 2004540 2025116 2056456 2108378 2146453 2277321 2301307

    Distribution

    Domestic distribution nationwide. International distribution worldwide.

    Quantity

    2,363,168 total units