Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
i-STAT G3+ cartridge (blue) Recalled by Abbott Point Of Care Inc. Due to Marketed without a 510(k). Abbott Point of Care...
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 G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
Quantity: 4,448,525
Why Was This Recalled?
Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.
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