Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
i-STAT CG4+ cartridge (white). List Number: 03P85-25. Recalled by Abbott Point Of Care Inc. Due to Lack of a 510(k) premarket clearance for the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Point Of Care Inc. directly.
Affected Products
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Quantity: 9,067,050 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Point Of Care Inc.
Abbott Point Of Care Inc. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report