FDA-Device2025-09-24Class II
i-STAT EG6+ cartridge. List Number: 03P77-25.
Abbott Point Of Care Inc.
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.
Sold states
US Nationwide distribution.
Affected count
547,250 units
Manufactured in
400 College Rd E, N/A, Princeton, NJ, United States
Products
i-STAT EG6+ cartridge. List Number: 03P77-25.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2585-2025Don't want to check this manually?
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