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 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.
The recall highlights the potential for inaccurate test results, which could lead to a higher frequency of misclassification in the positive and indeterminate zones. This may result in patients being incorrectly classified as having amyloid pathology associated with Alzheimer’s disease.
No specific incidents have been reported at this time. However, the potential for patients to receive misclassified results is considered a significant risk.
Patients and healthcare providers should stop using the Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators immediately. Contact Fujirebio Diagnostics, Inc. for further instructions and follow the recall procedures outlined in the notification letter.
For more information, contact Fujirebio Diagnostics, Inc. at their official website or call their customer support.
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