BEUDAMED
    FDA Enforcement Class II Ongoing

    API 20 E 25 STRIPS, CATALOG 20100

    Recall: Z-0784-2023 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0784-2023
    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

    API 20 E 25 STRIPS, CATALOG 20100

    Reason

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

    Code Info

    UDI/DI 03573026047818, Batch Number 1009226560

    Distribution

    US Nationwide distribution.

    Quantity

    1 unit