BEUDAMED
    FDA Enforcement Class II Terminated

    API 50 CH, Model 50300

    Recall: Z-0243-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0243-2022
    Event ID
    88844
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 24, 2021
    Initiation Date
    September 30, 2021
    Classification Date
    November 17, 2021
    Termination Date
    January 18, 2024
    Address
    100 Rodolphe St, N/A, Durham, NC, 27712-9402, United States

    Description

    API 50 CH, Model 50300

    Reason

    There is potential to provide an incorrect organism identification.

    Code Info

    Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230

    Distribution

    Distribution in WI, NY, and SD

    Quantity

    1382 kits