The Recall Desk
ModerateFDA (Devices)·Z-2582-2025·Announced 2025-09-24

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.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • regulatory-clearance
  • in-vitro-diagnostic
  • class-ii

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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