i-STAT EG7+ Cartridge Recalled for Lack of Premarket Clearance
Abbott Point Of Care is recalling i-STAT EG7+ cartridges nationwide because the updated sample types and measurement ranges for potassium, ionized calcium, pH, and PO2 were not cleared through the FDA's 510(k) premarket review process.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device recall involving a regulatory compliance issue—the updated specifications were not submitted through the FDA's 510(k) premarket clearance process. No illnesses, injuries, or device malfunctions are reported in the source. Per FDA rubric criteria, regulatory documentation issues without reported harm are classified as Moderate.
Plain-English summary
Abbott Point Of Care Inc. is recalling 6,115,950 units of i-STAT EG7+ cartridges (List Number: 03P76-25) nationwide. The recall affects all lot numbers of this product.
The i-STAT EG7+ cartridges are used in clinical laboratories to measure blood electrolytes and blood gases including potassium, ionized calcium, pH, and PO2. The product was marketed with updated sample types and measurement ranges for these parameters; however, these updates were not formally cleared through the FDA's 510(k) premarket clearance process.
Customers should contact Abbott Point Of Care Inc. for additional information regarding this recall.
The recalled product
- Product
- i-STAT EG7+ cartridge. List Number: 03P76-25.
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
- regulatory-non-compliance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- List Number: 03P76-25. All lot numbers.
Distribution
Distributed nationwide across the United States.
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