Abbott Point Of Care Inc. recalls i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914

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.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2583-2025
• FDA device classification · CHLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1120The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Abbott Point Of Care Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.