BEUDAMED
    FDA Enforcement Class II Ongoing

    i-STAT CG4+ cartridge (white). List Number: 03P85-25.

    Recall: Z-2582-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2582-2025
    Event ID
    97442
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 24, 2025
    Initiation Date
    August 21, 2025
    Classification Date
    September 17, 2025
    Address
    400 College Rd E, N/A, Princeton, NJ, 08540-6607, United States

    Description

    i-STAT CG4+ cartridge (white). List Number: 03P85-25.

    Reason

    Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

    Code Info

    List Number: 03P85-25. All lot numbers.

    Distribution

    US Nationwide distribution.

    Quantity

    9,067,050 units