Abbott Point Of Care Inc. has recalled approximately 9,067,050 i-STAT CG4+ cartridges (white) because the device was modified without required FDA premarket clearance. The updates affected the sample types used for lactate testing and the measurement ranges for pH and oxygen (PO2). Because these changes were not reviewed by the FDA, the accuracy and performance of the cartridges for these specific measurements have not been officially cleared.
The use of cartridges with uncleared measurement ranges or sample types could result in inaccurate diagnostic readings. Incorrect lactate, pH, or oxygen results could lead to delayed or inappropriate medical treatments for patients in clinical settings.
Manufacturer initiated correction or replacement.
The recall is due to lack of 510(k) premarket clearance for updated sample type for lactate and measurement ranges for pH and PO2.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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