Abbott Point Of Care Inc.: Device Recall
Recall #Z-2583-2025 · 08/21/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2583-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Abbott Point Of Care Inc.
- Status
- Ongoing
- Date Initiated
- 08/21/2025
- Location
- Princeton, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,962,450 units
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.
Product Description
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Distribution Pattern
US Nationwide distribution.
Other Recalls by Abbott Point Of Care Inc.
- Class II: Risk 08/21/2025
- Class II: Risk 08/21/2025
- Class II: Risk 08/21/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.