BEUDAMED
    FDA Enforcement Class II Ongoing

    BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.

    Recall: Z-1012-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-1012-2024
    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 Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.

    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. 230705 UDI-DI 00382902307051 Lots 1301474 1334111 2025840 2146318 2242344 2276051 2333100 3150355 3234179 ; Catalog No. 231264¿ UDI-DI 30382902312643 Lots 2333100 3030225 3058510 3150355 3234179 3282314 1301474 1334111 2003260 2025840 2146318 2242344 2276051; Catalog No. 231263 UDI-DI 30382902312636 Lots 3010977 3058508 3184064 3234190 1302042 2003517 2146414 2243865 2277199 2339360

    Distribution

    Domestic distribution nationwide. International distribution worldwide.

    Quantity

    2,363,168 total units