BEUDAMED
    FDA Enforcement Class II Ongoing

    BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿

    Recall: Z-1027-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-1027-2024
    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 Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿

    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. 231657¿ UDI-DI 00382902316572 Lots 1060926 1279842 2028533 2091948 2301402 3214964 3248370; Catalog No. 231658¿ UDI-DI 30382902316580 Lots 1335458 2336475 3062295 3093427 3163048 3214964 3248370 0344330 1007112 1060926 1127037 1279842 1335457 2028533 2028547 2091948 2091980 2301402 2336474

    Distribution

    Domestic distribution nationwide. International distribution worldwide.

    Quantity

    2,363,168 total units