Fujirebio Diagnostics recalled 128 units of Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators on December 11, 2025. The recall stems from the risk of inaccurate test results leading to misclassification of Alzheimer’s disease. Affected products may cause patients to receive unnecessary additional clinical testing.
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 ¿-Amyloid 1-42-N Plasma Calibrators are used in laboratory testing to measure amyloid plasma concentration, aiding in the diagnosis of Alzheimer's disease. These calibrators are essential for ensuring accurate test results in clinical settings.
Inaccurate test results arise due to falsely elevated positive or indeterminate ratios. This can mislead healthcare providers into classifying patients incorrectly, potentially delaying necessary treatment or further testing.
This recall is not part of a broader industry pattern.
Consumers may face significant implications due to the risk of misdiagnosis, leading to unnecessary anxiety and further clinical testing.
The model and lot numbers are typically found on the product packaging or accompanying documentation.
Expect a timeline of 4-6 weeks for refund processing after returning the product.
Keep all correspondence regarding the recall, including emails and letters. Document your return process with photos of the product.
The recalled product is Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators, Model Number 235454. These calibrators contain four concentrations and are distributed nationwide across various states including California and Texas. They were sold in liquid form, frozen, with volumes between 1 mL and 1.5 mL.
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