Fujirebio Diagnostics Recalls Lumipulse β-Amyloid Plasma Controls Over Inaccurate Alzheimer's Test Results

What Happened

Fujirebio Diagnostics, Inc. has initiated a voluntary recall of its Lumipulse β-Amyloid Plasma Controls. The company identified an issue where customers may experience inaccurate test results, specifically observing a higher frequency of classifications in the indeterminate and positive zones. This is caused by falsely elevated positive or indeterminate ratio results, which can lead to an incorrect classification of a patient as having amyloid pathology associated with Alzheimer’s disease or requiring additional, potentially unnecessary clinical testing.

Which Products Are Affected

The recall affects the following medical device components:

• Product Name: Lumipulse β-Amyloid Plasma Controls (Two levels of liquid frozen controls)
• Model/Catalog Number: 81559
• UDI-DI: 05414470815593
• Lot Number: T8B6116U
• Quantity: 179 units

The affected products were distributed to laboratories in the following states: Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, and Washington.

What You Should Do

Fujirebio Diagnostics, Inc. notified affected customers via an initial firm notification letter sent on December 11, 2025. Laboratories and healthcare providers using these controls should review their inventory for the affected lot number (T8B6116U) and follow the specific instructions provided in the manufacturer’s notification letter regarding the handling and use of the product.

Why This Matters

This recall is significant because inaccurate diagnostic results can lead to the misdiagnosis of Alzheimer’s disease, potentially causing patients to undergo further unnecessary medical testing or receive incorrect clinical assessments.

Source

Information provided by the FDA under recall number Z-1307-2026.