Recall Z-2583-2025— Abbott Point Of Care Inc.

Name: FDA recall Z-2583-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-21

Class II · Ongoing

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2025-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300. 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..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-21
Firm location: Princeton, NJ, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.