i-STAT CG4+ cartridge (white). List Number: 03P85-25.
This recall is currently active, issued September 17, 2025. It was issued by Abbott Point Of Care Inc..
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- August 21, 2025
- Posted
- September 17, 2025
- Recall Number
- Z-2582-2025
- Quantity
- 9,067,050 units
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution.
Lot / Code Info
List Number: 03P85-25. All lot numbers.
Root Cause
No Marketing Application
Action Taken
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.