Fujirebio Diagnostics Recalls Lumipulse G β-Amyloid 1-42-N Plasma Test Cartridges for Inaccurate Results

What Happened

Fujirebio Diagnostics, Inc. has initiated a voluntary recall of its Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges. The company identified a defect where customers may experience inaccurate test results, specifically observing a higher frequency of classifications in the indeterminate and positive zones. This issue results in low specificity when compared to FDA-cleared CSF ratio or PET imaging, potentially causing a patient to be incorrectly classified as having amyloid pathology associated with Alzheimer’s disease or requiring unnecessary additional clinical testing.

Which Products Are Affected

The recall involves 1,423 units distributed nationwide in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, and Washington.

• Product Name: Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC)
• Model/Catalog Number: 235447
• UDI-DI: 04987270235447
• Lot Numbers: C5C6022U, C5C6045U
• Recall Number: Z-1305-2026

What You Should Do

Fujirebio Diagnostics, Inc. began notifying customers via letter on December 11, 2025. Laboratories and healthcare providers in possession of the affected lot numbers (C5C6022U and C5C6045U) should immediately follow the instructions provided in the firm’s notification letter regarding the use and handling of these cartridges. For further information, consumers may contact Fujirebio Diagnostics, Inc. at their Malvern, Pennsylvania headquarters.

Why This Matters

This recall is significant because falsely elevated positive or indeterminate results can lead to the misdiagnosis of Alzheimer’s-related pathology, potentially resulting in inappropriate clinical management or the pursuit of unnecessary medical procedures for patients.

Source

Information provided by the FDA (Recall Event ID: 98232).