Reported Sep 24, 2025 · Ongoing
i-STAT EG7+ cartridge. List Number: 03P76-25.
Abbott Point Of Care Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Point Of Care Inc. · 400 College Rd E · Princeton, NJ · 08540-6607
Is this the product you have?
- i-STAT EG7+ cartridge
- List Number03P76-25
- Lot codes and dates
- List Number03P76-25. All lot numbers
- Amount recalled
- 6,115,950 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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