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 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.
The recall addresses potential inaccurate test results, leading to higher rates of indeterminate and positive classifications. This could cause patients to be incorrectly identified as having amyloid pathology associated with Alzheimer's disease.
No specific incidents or injuries have been reported. However, the risk of misclassification poses a significant concern for patient health.
Stop using the Lumipulse ¿-Amyloid Plasma Controls immediately. Contact Fujirebio Diagnostics or your healthcare provider for further instructions. Follow the recall guidelines provided in the notification letter.
For more information, contact Fujirebio Diagnostics at [insert phone number] or visit www.fujirebio.com.
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