Abbott Point Of Care recalled 9,067,050 i-STAT CG4+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance reflecting updated sample types and measurement ranges. Healthcare providers must stop using the device immediately and follow recall instructions.
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.
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 CG4+ cartridge, List Number: 03P85-25. The recall affects 9,067,050 units distributed nationwide in the US.
The i-STAT CG4+ cartridge lacks a 510(k) premarket clearance, which raises concerns about its accuracy and reliability. This could potentially lead to misdiagnosis or improper treatment.
No specific incidents or injuries have been reported in relation to this recall. The lack of clearance suggests a potential risk to patient safety.
Stop using the i-STAT CG4+ cartridge immediately. Contact Abbott Point Of Care Inc. or your healthcare provider for further instructions.
For more information, visit the recall page at the FDA website or contact Abbott Point Of Care Inc. directly.
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