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 is an in vitro diagnostic test that combines results from two assays to help assess amyloid pathology associated with Alzheimer's disease. Healthcare providers typically use this product for diagnosing patients based on plasma samples.
The risk arises from the potential for the test to yield falsely elevated positive or indeterminate results, which can misclassify a patient's condition and lead to inappropriate clinical decisions.
This recall is not part of a broader industry pattern.
The recall may lead to significant inconvenience for healthcare providers and patients, as it requires reevaluation of test results and may result in unnecessary additional testing.
The model number can typically be found on the product's packaging or the instruction manual included with the test kit.
Expect a response regarding refunds or replacements within 4-6 weeks after contacting Fujirebio Diagnostics.
Document all correspondence regarding the recall, including emails and phone calls, and keep any receipts or proof of purchase.
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.
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