Fujirebio Diagnostics recalled 23 units of its Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test on December 11, 2025. The recall follows concerns that the product may produce inaccurate test results, potentially misclassifying patients with Alzheimer's disease. Healthcare providers should stop using this device immediately and follow recall 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 Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test, Model CL0073, combines results from two assays into a numerical ratio. The product was distributed nationwide in 13 states, including California and Florida.
The device may classify test results inaccurately, leading to misdiagnosis of Alzheimer's disease. Health professionals may observe higher rates of indeterminate and positive classifications compared to established testing methods.
Patients and healthcare providers should stop using the Lumipulse G test immediately. Contact Fujirebio Diagnostics or your healthcare provider for instructions on the recall.
For more details, contact Fujirebio Diagnostics at [insert phone number] or visit their website at [insert website].
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