Fujirebio Diagnostics, Inc. is recalling approximately 3,587 units of its Lumipulse G pTau 217 and Amyloid plasma test kits, which are used to help identify Alzheimer's disease pathology. The recall was initiated because customers may receive inaccurate test results, including falsely elevated ratios that could incorrectly classify a patient as having amyloid pathology or requiring unnecessary additional testing. These diagnostic kits were distributed nationwide to clinical laboratories in 13 states.
Inaccurate test results could lead to a misdiagnosis of Alzheimer's disease or cause patients to undergo invasive or expensive follow-up testing based on false-positive or indeterminate findings.
Distribution related to the Ratio Instructions for Use (IFU).
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.
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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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