Abbott Point Of Care Inc. is recalling approximately 15,625,650 i-STAT CG8+, EG7+, and EG6+ blood analysis cartridges. These diagnostic tools were updated to include new sample types for potassium and ionized calcium and expanded measurement ranges for pH and PO2 without obtaining required FDA 510(k) premarket clearance. Using unvalidated diagnostic cartridges could result in inaccurate test readings, potentially leading to incorrect clinical decisions and patient harm. Laboratory personnel and healthcare providers should stop using the affected cartridges and contact the manufacturer for correction or replacement.
The updates to the cartridges' testing capabilities have not been validated through the FDA's premarket clearance process. This poses a risk that the diagnostic results provided by the cartridges for critical blood measurements may be inaccurate or unreliable.
510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300. Recall number Z-2583-2025.
Recall number Z-2584-2025.
Recall number Z-2585-2025.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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