i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Reported: September 24, 2025 Initiated: August 21, 2025 #Z-2583-2025
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.
Details
- Recalling Firm
- Abbott Point Of Care Inc.
- Units Affected
- 8,962,450 units
- Distribution
- US Nationwide distribution.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300. Recalled by Abbott Point Of Care Inc.. Units affected: 8,962,450 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 24, 2025. Severity: Moderate. Recall number: Z-2583-2025.
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