Abbott Point Of Care recalled 547,250 i-STAT EG6+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients must stop using these cartridges immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott Point Of Care Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The recalled product is the i-STAT EG6+ cartridge, List Number: 03P77-25. It was distributed nationwide in the U.S. and includes all lot numbers.
The cartridges lack the necessary 510(k) premarket clearance due to updates in sample types for potassium and ionized calcium. This affects the measurement ranges for pH and PO2.
No specific incidents or injuries have been reported related to this recall. The FDA classified this issue as a high hazard.
Stop using the i-STAT EG6+ cartridges immediately. Contact Abbott Point Of Care Inc. or your healthcare provider for further instructions.
For more information, visit the FDA website or contact Abbott Point Of Care Inc. directly through their official channels.
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