i-STAT EG6+ cartridge. List Number: 03P77-25.
Reported: September 24, 2025 Initiated: August 21, 2025 #Z-2585-2025
Product Description
i-STAT EG6+ cartridge. List Number: 03P77-25.
Reason for Recall
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.
Details
- Recalling Firm
- Abbott Point Of Care Inc.
- Units Affected
- 547,250 units
- Distribution
- US Nationwide distribution.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
i-STAT EG6+ cartridge. List Number: 03P77-25.. Recalled by Abbott Point Of Care Inc.. Units affected: 547,250 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 24, 2025. Severity: Moderate. Recall number: Z-2585-2025.
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