Fujirebio Diagnostics recalled 179 units of Lumipulse ¿-Amyloid Plasma Controls on December 11, 2025. The recall stems from inaccurate test results leading to potential misclassification of Alzheimer's disease. Customers should stop using the device immediately and follow the manufacturer's instructions.
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 ¿-Amyloid Plasma Controls are used as quality control in laboratories analyzing amyloid levels in plasma. They are essential for ensuring accurate test results in Alzheimer's disease diagnostics.
The product may yield inaccurate results, causing patients to be misclassified regarding their Alzheimer's disease status. This can lead to unnecessary additional testing or incorrect treatment paths.
This recall is not part of a broader industry pattern.
The recall may lead to confusion and anxiety among patients awaiting test results, as well as potential delays in receiving appropriate care.
Product model and lot numbers are typically found on the packaging or in the accompanying documentation.
Expect a refund or replacement processing time of approximately 4 to 8 weeks.
Keep copies of your purchase receipt, recall notification letters, and any correspondence with the manufacturer.
The recalled product is Lumipulse ¿-Amyloid Plasma Controls, Model/Catalog Number 81559. The product contains Tris buffer with protein and chemical stabilizers, and it was sold nationwide in the U.S. between unspecified dates.
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