Device product

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

Z-2583-2025

August 21, 2025

Class II

Product summary

Firm: Abbott Point Of Care Inc.
Event: Event 97443
Status: Ongoing
Classification: Class II
Quantity: 8,962,450 units
Official record key: device-enforcement:Z-2583-2025

Official wording

Reason: 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.

Code information: List Number: 03P88-25. All lot numbers.

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.