Abbott Point Of Care Inc.: Device Recall

Recall #Z-2584-2025 · 08/21/2025

Class II: Risk

Recall Details

Recall Number: Z-2584-2025
Classification: Class II
Product Type: Device
Recalling Firm: Abbott Point Of Care Inc.
Status: Ongoing
Date Initiated: 08/21/2025
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6,115,950 units

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.

Product Description

i-STAT EG7+ cartridge. List Number: 03P76-25.

Distribution Pattern

US Nationwide distribution.

Other Recalls by Abbott Point Of Care Inc.

Class II: Risk 08/21/2025

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.
Class II: Risk 08/21/2025

Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Class II: Risk 08/21/2025

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.

View all recalls by Abbott Point Of Care Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.