Fujirebio Diagnostics recalled 148 units of Lumipulse pTau 217 Plasma Controls on December 11, 2025. The recall follows reports of inaccurate test results that misclassify patients regarding Alzheimer’s disease. The affected product may falsely elevate positive or indeterminate results, increasing the risk of incorrect patient classification.
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fujirebio Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Lumipulse pTau 217 Plasma Controls are used in laboratories to ensure accurate testing of Alzheimer’s disease through plasma analysis. They help assess the performance of laboratory procedures and techniques.
The controls may produce falsely elevated results for patients, leading to incorrect classifications regarding Alzheimer’s disease. This can result in unnecessary follow-up testing and misdiagnosis.
This recall is not part of a broader industry pattern.
Consumers relying on these products for accurate Alzheimer’s testing may face serious implications due to potential misdiagnosis. This could lead to emotional stress and unnecessary additional tests.
Serial numbers and lot numbers can typically be found on the product label or accompanying documentation.
Expect a response regarding refunds or replacements within 4-6 weeks.
Keep a copy of your purchase receipt and any correspondence regarding the recall.
The recall affects the Lumipulse pTau 217 Plasma Controls, Model/Catalog Number: 81558. The product contains Tris buffer, bovine protein, and chemical stabilizers, with a preservative of ProClin. It was distributed nationwide across multiple states including California and Texas.
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