A recall affecting the first blood test the FDA ever cleared for Alzheimer's disease is still listed as open in the agency's device database, nine months after the manufacturer first told laboratories to stop using four specific reagent lots.
The FDA device recall record for the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, made by Fujirebio Diagnostics of Malvern, Pennsylvania, was last updated on September 11, 2026. Logged as recall number Z-1302-2026 and posted in February, it remains classified as a Class 2 recall with a status of open, meaning not all affected product has been corrected or removed.
