FDAFDA · Food and drugs·Recall number Z-2585-2025
i-STAT EG6+ cartridge. List Number: 03P77-25.
Published September 24, 2025 · Recall initiated: August 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Abbott Point Of Care Inc.
- Distributor
- US Nationwide distribution.
- Lot
- List Number: 03P77-25. All lot numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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