Fujirebio Diagnostics has recalled 117 units of Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results. The recall was announced on December 11, 2025, after customers reported false classifications of Alzheimer’s disease. Affected products were distributed nationwide, including in states like California and Florida.
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 pTau 217 Plasma Calibrator, Model/Catalog Number 81557. The product includes five concentrations: CAL 1 (0 pg/mL), CAL 2 (0.250 pg/mL), CAL 3 (1.000 pg/mL), CAL 4 (5.000 pg/mL), and CAL 5 (10.000 pg/mL). It was distributed across several states in the U.S.
The calibrators may yield inaccurate results, showing a higher frequency of indeterminate and positive classifications. This can lead to false indications of amyloid pathology in patients, increasing unnecessary clinical testing.
No specific injury reports have been noted, but the potential for misdiagnosis represents a significant risk to patient health. This could lead to inappropriate treatment plans for patients.
Stop using the Lumipulse G pTau 217 Plasma Calibrators immediately. Follow the recall instructions provided by Fujirebio Diagnostics. Contact the manufacturer or your healthcare provider for further instructions.
For further assistance, contact Fujirebio Diagnostics, Inc. at their official website or follow the instructions in the recall notification letter.
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