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Abbott Point Of Care Inc. recalls i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Recalled September 24, 2025 · FDA recall Z-2582-2025 · Abbott Point Of Care
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. · FDA Class II
Units
9,067,050 units
Sold at
US Nationwide distribution.
Description
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.
Product
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Manufacturer(s)
Abbott Point Of Care Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →