Abbott Point Of Care Inc. recalls i-STAT CG4+ cartridge (white). List Number: 03P85-25.

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.

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

Abbott notified consignees via email and letter on about 08/21/2025. Consignees were instructed to download, review and implement the updated i-STAT CG4+ cartridge Instructions for Use (IFU), discontinue use of the i-STAT CG4+ cartridges for testing of capillary whole blood samples for lactate and instead use venous or arterial whole blood or an alternate method for testing capillary whole blood for lactate, and update the pH and PO2 reportable ranges on the i-STAT 1 analyzers running i-STAT CG4+ cartridges. 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). 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 CG4+ cartridges to another facility, they were requested to notify them.

• FDA enforcement recordOfficial FDA database entry for Z-2582-2025
• FDA 510(k) clearance · K244014The device's official FDA premarket clearance record
• FDA 510(k) clearance · K940918The device's official FDA premarket clearance record
• FDA 510(k) clearance · K982071The device's official FDA premarket clearance record
• 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.