Blood gas CG8+ cartridges recalled for lacking updated premarket clearance
i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.
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: Rubric level 2 covers precautionary recalls; the issue is a regulatory clearance gap for updated claims rather than any defect described in the product.
Plain-English summary
The i-STAT CG8+ cartridge, list number 03P88-25, is being recalled across all lot numbers. The recall covers 8,962,450 units distributed nationwide in the United States.
The recall was issued for lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect the updated sample type for potassium and ionized calcium and the measurement ranges for pH and PO2. The FDA classified the action as Class II. The notice does not describe a defect in the cartridges.
Laboratories and hospitals using these cartridges should follow the manufacturer's instructions.
The recalled product
- Product
- i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
- Manufacturer
- Abbott Point Of Care Inc.
- Affected units
- 8,962,450
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: 03P88-25. All lot numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Abbott Point Of Care Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Abbott Point Of Care Inc.
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