i-STAT CG4+ cartridge (white). List Number: 03P85-25.
FDA Recall #Z-2582-2025 — Class II — August 21, 2025
Product Description
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
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.
Recalling Firm
Abbott Point Of Care Inc. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9,067,050 units
Distribution
US Nationwide distribution.
Code Information
List Number: 03P85-25. All lot numbers.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated