Abbott Point Of Care recalled 9,067,050 i-STAT CG4+ cartridges sold nationwide in the United States. The recall cites a lack of 510(k) premarket clearance to reflect updated sample type for lactate and measurement ranges for pH and PO2. Patients and healthcare providers should stop using the device immediately and follow manufacturer 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
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The i-STAT CG4+ cartridge is used with blood gas and lactate testing within point-of-care systems, enabling rapid clinical results.
The lack of 510(k) clearance for updated sample type and measurement ranges could lead to misinterpretation of test results.
This recall is not described as part of a broader industry pattern in the provided data.
Immediate stop-use is required to prevent potential misinterpretation of critical test results in point-of-care settings.
Refer to FDA recall Z-2582-2025 page and Abbott communications; contact manufacturer for confirmation
Remedy timelines are determined by Abbott and disclosed in recall communications; expect updates
Retain recall notifications, packaging, receipts, and correspondence for records
Model numbers: List Number 03P85-25. All lot numbers. Distribution: US nationwide. Quantity: 9,067,050 units. Remedy: Stop use and follow recall instructions. Manufacturer contact: Abbott Point Of Care Inc.
No incidents or injuries are reported in the provided data.
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