Fujirebio Diagnostics recalled 1,423 units of Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects models found to provide inaccurate test results, potentially misclassifying Alzheimer's disease. Healthcare providers and patients should stop using these cartridges 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 ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges are used for quantitative measurement of ¿-Amyloid 1-42 in plasma specimens. They are primarily utilized in clinical settings to assist in the diagnosis of Alzheimer’s disease.
The cartridges can yield inaccurate results, classifying patients incorrectly as having Alzheimer's pathology. This can lead to unnecessary further testing and misdiagnosis.
This recall is not part of a broader industry pattern.
Patients and healthcare providers may face delays in diagnosis and additional testing due to inaccurate results.
The model number can usually be found on the product packaging or labeling.
Refund processing typically takes 4-6 weeks after the recalled product is returned.
Keep receipts, communications with the manufacturer, and any records of your usage of the product.
The recalled product is the Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges, Model 235447. It includes 14 cartridges per rack and is distributed nationwide in states including California, Florida, and Texas. The product was sold as part of an assay system for measuring ¿-Amyloid 1-42 in K2EDTA plasma specimens.
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