BEUDAMED
    FDA Enforcement Class II Ongoing

    ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333

    Recall: Z-0823-2023 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0823-2023
    Event ID
    91148
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biomerieux Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 11, 2023
    Initiation Date
    November 9, 2022
    Classification Date
    January 4, 2023
    Address
    595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States

    Description

    ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333

    Reason

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

    Code Info

    UDI/DI 03573026377557, Batch Numbers: 1009157090

    Distribution

    US Nationwide distribution.

    Quantity

    5 units