Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance for updated measurement ranges. This issue affects the accuracy of potassium and ionized calcium tests, posing a high risk to patients.
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
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The recall involves i-STAT EG7+ cartridges, List Number: 03P76-25. The cartridges were distributed nationwide in the U.S. and include all lot numbers.
The cartridges lack the necessary 510(k) premarket clearance. This affects the measurement ranges for potassium, ionized calcium, pH, and PO2, leading to potentially inaccurate test results.
There have been no specific incidents reported associated with the recalled cartridges. However, the lack of clearance poses a high risk to patient safety.
Stop using the i-STAT EG7+ cartridges immediately. Follow the recall instructions from Abbott Point Of Care Inc. or your healthcare provider.
For further instructions, contact Abbott Point Of Care Inc. or visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2584-2025.
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