Class II

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

Abbott Point Of Care Inc. · August 21, 2025

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

8,962,450 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2583-2025

Status: ongoing

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