Fujirebio

Fujirebio is recalling quality control materials used in Alzheimer's disease testing labs. The controls may give falsely high or indeterminate results, causing patients to be incorrectly classified as having amyloid pathology or to receive unnecessary additional testing. This affects Model 81559, Lot T8B6116U, distributed in 13 U.S. states.

Fujirebio Diagnostics is recalling calibrator kits (model 235454, specific lot numbers) used in a blood test for Alzheimer's disease risk. The calibrators may cause inaccurate results, falsely flagging patients as positive or indeterminate for amyloid pathology when they should not be, or missing cases that should be detected.

Fujirebio Diagnostics is recalling Lumipulse G β-Amyloid 1-42 Plasma test cartridges (Model 235447, certain lot numbers) because they may produce falsely high or falsely indeterminate results. This could incorrectly classify patients as having Alzheimer's disease pathology or unnecessarily recommend further testing. Healthcare providers should stop using affected cartridges immediately.

Fujirebio Diagnostics is recalling Lumipulse pTau 217 Plasma Controls (Model 81558) used in laboratory testing for Alzheimer's disease markers. The controls may produce falsely elevated results, leading labs to incorrectly classify patients as having Alzheimer's disease or requiring additional testing.

Fujirebio Diagnostics' Lumipulse G pTau 217 Plasma Calibrators (Model 81557) may produce inaccurate test results, causing patients to be incorrectly classified as having Alzheimer's-related amyloid pathology or flagged for unnecessary additional testing. The calibration issue leads to falsely elevated results that do not match established imaging and CSF tests.

Fujirebio's Lumipulse G pTau 217 Plasma test cartridges (Model 81550) may produce inaccurate results, incorrectly classifying patients as having Alzheimer's-related amyloid pathology or flagging them for unnecessary further testing. The cartridges show higher rates of false-positive and false-indeterminate results compared to FDA-approved reference tests. Affected lot numbers are D4C6028U, D4C6029U, D4C6051U, and D4C6052U.

Fujirebio's Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test may produce inaccurate results that falsely suggest Alzheimer's disease or incorrectly flag patients for additional testing. The test can show higher-than-actual ratios, leading to wrong patient classifications compared to confirmed imaging or cerebrospinal fluid tests.