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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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