Fujirebio Diagnostics Recalls Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Test Due to Inaccurate Results

What Happened

Fujirebio Diagnostics, Inc. has initiated a voluntary recall of the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio diagnostic test. The company identified that customers may experience inaccurate test results, specifically a higher frequency of indeterminate or positive classifications and low specificity when compared to FDA-cleared CSF ratio or PET imaging. This issue is caused by falsely elevated positive or indeterminate ratio results, which can lead to a patient being incorrectly classified as having amyloid pathology associated with Alzheimer’s disease or requiring unnecessary additional clinical testing.

Which Products Are Affected

The recall affects the following diagnostic product and its associated components:

• Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
• Model/Catalog Number: CL0073
• UDI-DI: 00869164000086
• Recall Number: Z-1301-2026
• Quantity: 23 units
• Affected Components: The recall involves several imported kits, including Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (81550), Calibrators (81557), and Controls (81558), as well as Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges (235447), Calibrators (235454), and Controls (81559).

Distribution Area: The affected units were distributed nationwide 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 consignees via an initial firm notification letter sent on December 11, 2025. Laboratory professionals and healthcare providers using this diagnostic ratio should follow the instructions provided in the firm’s notification. For further information regarding returns or technical guidance, contact Fujirebio Diagnostics, Inc. at their Malvern, PA location.

Why This Matters

This recall is significant because inaccurate diagnostic results can lead to the misdiagnosis of amyloid pathology associated with Alzheimer’s disease. Such errors may result in patients undergoing unnecessary medical procedures or receiving incorrect clinical management based on false-positive or indeterminate test outcomes.

Source

Information provided by the FDA under recall number Z-1301-2026.