i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K23...
FDA Recall #Z-2583-2025 — Class II — August 21, 2025
Product Description
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Reason for Recall
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.
Recalling Firm
Abbott Point Of Care Inc. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8,962,450 units
Distribution
US Nationwide distribution.
Code Information
List Number: 03P88-25. All lot numbers.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated