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Abbott Point Of Care Inc. recalls i-STAT EG7+ cartridge. List Number: 03P76-25.
Recalled September 24, 2025 · FDA recall Z-2584-2025 · Abbott Point Of Care
Hazard
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. · FDA Class II
Units
6,115,950 units
Sold at
US Nationwide distribution.
Description
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
i-STAT EG7+ cartridge. List Number: 03P76-25.
Manufacturer(s)
Abbott Point Of Care Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →