Blood gas cartridges recalled for lacking clearance covering updated measurement ranges
i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 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 CG4+ cartridge (white), list number 03P85-25, is being recalled across all lot numbers. The recall covers 9,067,050 units distributed nationwide in the United States.
The recall was issued for lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect the updated sample type for lactate 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 CG4+ cartridge (white). List Number: 03P85-25.
- Manufacturer
- Abbott Point Of Care Inc.
- Affected units
- 9,067,050
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: 03P85-25. All lot numbers.
Distribution
Distributed nationwide across the United States.
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