Abbott Point Of Care Inc. recalls i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
- Recall date
- August 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2583-2025
- FDA classification
- Class II
- Brand / firm
- Abbott Point Of Care Inc.
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
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