Fujirebio Diagnostics recalled 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects users due to potential inaccurate test results associated with Alzheimer's disease classifications. Customers in 13 states should stop using the product immediately.
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 G pTau 217 Plasma Immunoreaction Cartridges are used for measuring pTau 217 levels in plasma specimens, which aids in diagnosing Alzheimer's disease. Healthcare professionals commonly use these cartridges in clinical settings to assess patients' cognitive health.
The cartridges pose a risk of providing false classifications of Alzheimer's disease due to inaccurate test results. This can lead to misdiagnosis and unnecessary follow-up testing for patients.
This recall is not part of a broader industry pattern.
Patients may experience delays in accurate diagnosis and treatment, leading to increased healthcare costs and emotional stress.
The model and lot numbers are typically found on the product packaging or accompanying documentation.
Expect a refund or replacement process to take approximately 4-6 weeks after returning the product.
Keep a record of your purchase, any correspondence with the manufacturer, and photos of the product for your records.
The recall involves Lumipulse G pTau 217 Plasma Immunoreaction Cartridges, Model/Catalog Number: 81550. A total of 1,569 units were distributed across 13 states in the U.S.
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