Abbott Point Of Care Inc.
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Abbott Point Of Care Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-24FDA-DeviceClass IIi-STAT EG6+ cartridge. List Number: 03P77-25.
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.
- 2025-09-24FDA-DeviceClass IIi-STAT EG7+ cartridge. List Number: 03P76-25.
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.
- 2025-09-24FDA-DeviceClass IIi-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
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.
- 2025-09-24FDA-DeviceClass IIi-STAT CG4+ cartridge (white). List Number: 03P85-25.
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.
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