BEUDAMED
    FDA Enforcement Class II Ongoing

    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿

    Recall: Z-1026-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-1026-2024
    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 Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿

    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. 230733¿¿ UDI-DI 00382902307334 Lots 1020750 1116997 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 2277205 3003821 3129527 3263117 9336993 0080290 0178844 0258758; Catalog No. 231274¿ UDI-DI 30382902312742 Lots 2277205 3003821 3129527 3263117 0057245 0080290 1057453 1116997 1148461 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 9336993

    Distribution

    Domestic distribution nationwide. International distribution worldwide.

    Quantity

    2,363,168 total units