Abbott Point Of Care recalled 8,962,450 i-STAT CG8+ cartridges sold nationwide in the United States. The recall stems from a lack of FDA 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using these cartridges and follow Abbott's recall instructions.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott Point Of Care Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The i-STAT CG8+ cartridge is used with the i-STAT handheld analyzer to perform rapid blood tests at point of care. It is part of a family of cartridges for electrolyte, pH, and gas measurements.
The absence of 510(k) clearance for updated cartridge configurations could lead to incorrect or unvalidated test results if used clinically.
This recall is not part of a broader industry pattern.
Hospitals and clinics rely on these cartridges for rapid testing. The recall interrupts testing workflows and may require validation steps to ensure accurate results with alternative cartridges.
FDA recall page Z-2583-2025 and Abbott Point Of Care recall notices.
Recall notification indicates immediate stopping of use. Replacement or remediation details will be provided by Abbott; timelines are not specified in
Keep recall notices, packaging, and any correspondence. Photograph lot numbers and List Numbers for records.
List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300. Distribution: US Nationwide. Quantity: 8,962,450 units. Sold at: Not specified in recall notice.
No injuries or incidents have been reported.
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