Safety Alert: Class II: 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.
healthClass IIRecalled on Sep 24, 2025
i-STAT EG6+ cartridge. List Number: 03P77-25.
🔢 547,250 units
Sold At: Abbott Point Of Care Inc.(US Nationwide distribution.)
Recall #: FDA-DEVICE-Z-2585-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- List Number: 03P77-25. All lot numbers.
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Summary
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.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Abbott Point Of Care Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.