Fujirebio Diagnostics Recalls Lumipulse pTau 217 Plasma Controls Due to High Risk of Inaccurate Test
Fujirebio Diagnostics recalled 148 units of Lumipulse pTau 217 Plasma Controls on December 11, 2025. The recall follows reports of inaccurate test results that misclassify patients regarding Alzheimer’s disease. The affected product may falsely elevate positive or indeterminate results, increasing the risk of incorrect patient classification.