Recall Z-2583-2025 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
| Date | Sep 17, 2025 (initiated Aug 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | No Marketing Application |
| Action | Abbott notified consignees via email and letter on about 08/21/2025. Consignees were instructed to download, review and implement the updated i-STAT CG8+, EG7+ and EG6+ cartridge Instructions for Use (IFU), discontinue use of i-STAT CG8+, EG7+ and EG6+ cartridges for testing of capillary whole blood samples for potassium and ionized calcium, and use venous or arterial whole blood or an alternate method for testing capillary potassium and ionized calcium. Update the pH and PO2 reportable ranges on the i-STAT 1 analyzers running i-STAT CG8+, EG7+ or EG6+ cartridges. As this feature is not custom |
| Quantity | 8,962,450 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.