Fujirebio Diagnostics recalled 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects users due to potential inaccurate test results associated with Alzheimer's disease classifications. Customers in 13 states should stop using the product 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 recall involves Lumipulse G pTau 217 Plasma Immunoreaction Cartridges, Model/Catalog Number: 81550. A total of 1,569 units were distributed across 13 states in the U.S.
Customers may receive inaccurate test results, with an increased chance of false classifications regarding amyloid pathology linked to Alzheimer's disease. This could lead to unnecessary clinical tests and misdiagnosis.
No specific incidents or injuries have been reported. The hazard is classified as a high risk due to potential misdiagnosis.
Stop using the Lumipulse G pTau 217 Plasma Immunoreaction Cartridges immediately. Follow recall instructions from Fujirebio Diagnostics and consult your healthcare provider.
For further information, contact Fujirebio Diagnostics, Inc. or visit their website. More details are available at the FDA recall page.
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