BEUDAMED
    FDA Enforcement Class II Ongoing

    i-STAT EG7+ cartridge; List Number: 03P76-25;

    Recall: Z-1999-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-1999-2026
    Event ID
    98635
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2026
    Initiation Date
    April 1, 2026
    Classification Date
    April 29, 2026
    Address
    400 College Rd E, Princeton, NJ, 08540-6607, United States

    Description

    i-STAT EG7+ cartridge; List Number: 03P76-25;

    Reason

    Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

    Code Info

    List Number: 03P76-25; UDI-DI: 00054749000043; Lot numbers: N25206, N25207, N25209, N25213, N25218, N25219, N25233;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA, BANGLADESH, BELGIUM, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, LUXEMBOURG, MAURITIUS, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.

    Quantity

    369650 units (150875 US, 218775 OUS)