Fujirebio Diagnostics Recalls Lumipulse G Beta-Amyloid 1-42-N Plasma Calibrators Due to Inaccurate Test Results

What Happened

Fujirebio Diagnostics, Inc. has initiated a voluntary Class II recall of its Lumipulse G β-Amyloid 1-42-N Plasma Calibrators. The recall was prompted by the discovery that customers may experience inaccurate test results. Specifically, the product may produce a higher frequency of classifications in the indeterminate and positive zones, or show low specificity compared to FDA-cleared CSF ratio/PET imaging. This is due to falsely elevated positive or indeterminate ratio results.

Which Products Are Affected

The recall affects 128 units distributed nationwide across 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 Calibrators
• Model/Catalog Number: 235454
• UDI-DI: 04987270235454
• Lot Numbers: D8C6022U, D8C6044U
• Components: Liquid (Frozen), 1 x 1.5 mL (4 Concentrations: CAL 1, CAL 2, CAL 3, CAL 4)

What You Should Do

Fujirebio Diagnostics, Inc. notified affected customers via letter on December 11, 2025. Facilities and laboratories using these calibrators should immediately check their inventory for the specified lot numbers (D8C6022U and D8C6044U). If these lots are found, users should follow the instructions provided in the firm’s notification letter regarding the handling of the affected product. For further inquiries, the recalling firm is located at 201 Great Valley Pkwy, Malvern, PA 19355-1308.

Why This Matters

Inaccurate results from these calibrators can lead to the incorrect classification of a patient as having amyloid pathology associated with Alzheimer’s disease. This may result in a false positive diagnosis or lead to patients undergoing additional, unnecessary clinical testing due to indeterminate results.

Source

This information is based on official recall data provided by the FDA under recall number Z-1306-2026.