BEUDAMED
    FDA Recall Open, Classified

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    Recall: Z-2583-2025 · Initiated August 21, 2025

    Recall

    Recall Number
    Z-2583-2025
    Event Number
    97443
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    CHL
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    August 21, 2025
    Posted
    September 17, 2025
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    Reason

    Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

    Action

    Abbott notified consignees via email and letter on about 08/21/2025. Consignees were instructed to download, review and implement the updated i-STAT CG8+, EG7+ and EG6+ cartridge Instructions for Use (IFU), discontinue use of i-STAT CG8+, EG7+ and EG6+ cartridges for testing of capillary whole blood samples for potassium and ionized calcium, and use venous or arterial whole blood or an alternate method for testing capillary potassium and ionized calcium. Update the pH and PO2 reportable ranges on the i-STAT 1 analyzers running i-STAT CG8+, EG7+ or EG6+ cartridges. As this feature is not customizable through the i STAT 1 handheld keypad, please see the i STAT DE Quick Reference Guide - Customizing Reportable Ranges (ART 770547-00 Revision A) for more information. To use the Custom Reportable Range feature, you must have the i-STAT 1 handheld and i STAT DE version 2.3 or higher. Changes to the reportable range may require a change to the Laboratory Information System (LIS) interface. Additionally, consignees were requested to confirm receipt and understanding of this communication by responding to the business reply card included with the letter. If consignees have forwarded any i-STAT CG8+, EG7+ or EG6+ cartridges to another facility, they were requested to notify them.

    Distribution

    US Nationwide distribution.

    Quantity

    8,962,450 units