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 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.
The cartridges may yield inaccurate test results, particularly false positives or indeterminate results. This misclassification can lead to unnecessary additional clinical testing and potential misdiagnosis of Alzheimer's disease.
There are no reported injuries or deaths associated with this recall. The issue affects test specificity and classification accuracy, but no adverse health outcomes have been documented.
Stop using the Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges immediately. Healthcare providers should follow the recall instructions and contact Fujirebio Diagnostics for further guidance.
Contact Fujirebio Diagnostics, Inc. for more information. Visit their website or call their customer service for instructions regarding the return of affected products.
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