Recall Z-2582-2025 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
| Date | Sep 17, 2025 (initiated Aug 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| 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 CG4+ cartridge Instructions for Use (IFU), discontinue use of the i-STAT CG4+ cartridges for testing of capillary whole blood samples for lactate and instead use venous or arterial whole blood or an alternate method for testing capillary whole blood for lactate, and update the pH and PO2 reportable ranges on the i-STAT 1 analyzers running i-STAT CG4+ cartridges. This feature is not customizable through the i-STAT 1 handheld keypad, please see the |
| Quantity | 9,067,050 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |