i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    List Number: 03P85-25. All lot numbers.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Abbott Point Of Care Inc.
Reason for Recall:
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Product Codes/Lot Numbers:

List Number: 03P85-25. All lot numbers.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2582-2025

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Class I - Dangerous

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

Aug 21, 2025 Other Medical Devices Nationwide View Details →