FDA-Device2025-09-24Class II
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Abbott Point Of Care Inc.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
9,067,050 units
Manufactured in
400 College Rd E, N/A, Princeton, NJ, United States
Products
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2582-2025Don't want to check this manually?
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