BEUDAMED
    FDA Enforcement Class II Ongoing

    BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿

    Recall: Z-1020-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-1020-2024
    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 Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿

    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. 231606 UDI-DI 00382902316060 Lots 2004580 2025164 2090467 2146516 2180432 2301360 3003886; Catalog No. 231607 UDI-DI 30382902316078 Lots 2301360 3062270 3158078 3261093 2004580 2025164 2090467 2146516 2180432 3003886; Catalog No. 291308¿ UDI-DI N/A Lots 2301468 3003046 3093596 3116037 3248537 3248540

    Distribution

    Domestic distribution nationwide. International distribution worldwide.

    Quantity

    2,363,168 total units