BEUDAMED
    FDA Recall Open, Classified

    i-STAT EG6+ cartridge; List Number: 03P77-25;

    Recall: Z-2000-2026 · Initiated April 1, 2026

    Recall

    Recall Number
    Z-2000-2026
    Event Number
    98635
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    CHL
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    April 1, 2026
    Posted
    April 29, 2026
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT EG6+ cartridge; List Number: 03P77-25;

    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.

    Action

    On April 1, 2026, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. This Urgent Medical Device Corrective is to customers in the U.S. with the following recommended actions: " Discontinue use of the affected i-STAT EG7+, EG6+, and G3+ cartridge lots for reporting PCO and pH results. " Use an alternate cartridge type, alternate lot, or testing method. " Complete and return the Business Reply Card included with this notification to confirm receipt and understanding. If you have forwarded any of the specified i-STAT EG7+, EG6+ or G3+ cartridges to another facility, we request that you please provide a copy of this letter to them.

    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

    30775 units (25625 US, 5150 OUS)