Nova Biomedical Corporation has recalled approximately 1,940 units of its Stat Profile Prime Plus Analyzers due to a defect where the devices may report incorrect creatinine levels in patients. This issue specifically occurs during the first 2 to 4 hours after a new BUN/Creatinine Sensor Cartridge is installed and may not be detected by standard quality control checks. The recall affects several models, including newly manufactured and remanufactured units with specific software versions. Healthcare facilities and laboratories using these diagnostic tools should follow the manufacturer's guidance to prevent potential misdiagnosis or improper patient treatment.
The device may provide inaccurate creatinine readings shortly after a cartridge change, which could lead to incorrect clinical decisions regarding a patient's kidney function or the administration of medications that rely on accurate renal monitoring.
Manufacturer initiated correction and notification
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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