Class II
Medical Device Recall: i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Abbott Point Of Care Inc. · August 21, 2025
Reason for Recall
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.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
9,067,050 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2582-2025
Status: ongoing
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