BEUDAMED
    FDA Enforcement Class II Ongoing

    BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿

    Recall: Z-1030-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-1030-2024
    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 Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿

    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. 232174 UDI-DI 00382902321743 Lots 1301766 1341479 2119610 2147329 2242618 2276113 2333166 3152004 3181140; Catalog No. 232175¿ UDI-DI 30382902321751 Lots 1301766 2276113 2333166 2333175 3152004 3181140 1341479 2119610 2119612 2147329 2242618

    Distribution

    Domestic distribution nationwide. International distribution worldwide.

    Quantity

    2,363,168 total units