Abbott Point Of Care recalled 8,962,450 i-STAT CG8+ cartridges on August 21, 2025. The recall affects cartridges lacking proper 510(k) premarket clearance for updated sample types. Patients and healthcare providers must stop using these devices 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 recall affects the i-STAT CG8+ cartridge, List Number: 03P88-25. The affected 510(k) numbers include K894914, K940918, K223710, K230275, K230285, and K230300. The cartridges were distributed nationwide in the U.S.
The cartridges lack 510(k) premarket clearance for updated sample types related to potassium and ionized calcium measurements. This may lead to incorrect test results for pH and PO2 levels, posing a risk to patient safety.
There have been no reported incidents or injuries associated with this recall. However, the classification as Class II indicates a high hazard risk.
Stop using the i-STAT CG8+ cartridge immediately. Follow the recall instructions provided by Abbott Point Of Care. Contact your healthcare provider for further guidance.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2583-2025. Alternatively, contact Abbott Point Of Care Inc. directly.
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