# FDA recall Z-2583-2025

> **Abbott Point Of Care Inc.** · Class II · device recall initiated 2025-08-21.

## Product

i-STAT CG8+ cartridge. List Number: 03P88-25.      510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

## Reason for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2583-2025
- **Recalling firm:** Abbott Point Of Care Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-21
- **Report date:** 2025-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2583-2025

## Citation

> AI Analytics. FDA recall Z-2583-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2583-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*