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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Abbott Point Of Care Inc. Medical Device Recall: i-STAT CG4+ cartridge (white). List Number: 03P85-25. | SafeCheck