FDAHealthAugust 21, 2025
Abbott Point Of Care Inc. — i-STAT EG6+ cartridge. List Number: 03P77-25.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 21, 2025
US Nationwide distribution.
What's affected?
- Product
- i-STAT EG6+ cartridge. List Number: 03P77-25.
- Lot code
- s
Additional details
List Number: 03P77-25. All lot numbers.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 547,250 units.
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