Fujirebio Diagnostics Recalls Lumipulse G pTau 217 Plasma Calibrators Due to Inaccurate Test Results

What Happened

Fujirebio Diagnostics, Inc. has initiated a voluntary recall of its Lumipulse G pTau 217 Plasma Calibrators. The recall was issued because customers may experience inaccurate test results, specifically observing a higher frequency of classification in the indeterminate and positive zones. This is due to falsely elevated positive or indeterminate ratios, which can cause a patient to be incorrectly classified as having amyloid pathology associated with Alzheimer’s disease or require unnecessary additional clinical testing.

Which Products Are Affected

The recall affects 117 units of the following diagnostic device components:

• Product Name: Lumipulse G pTau 217 Plasma Calibrators
• Model/Catalog Number: 81557
• UDI-DI: 05414470815579
• Lot Numbers: D5C6094U and D5C6125U
• Recall Number: Z-1303-2026

Distribution was nationwide across 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 letter starting December 11, 2025. Laboratories and healthcare providers using these calibrators should check their inventory for the specified lot numbers (D5C6094U, D5C6125U) and follow the instructions provided in the firm’s notification letter regarding the use of these products and any necessary corrective actions.

Why This Matters

Inaccurate diagnostic results in Alzheimer’s screening can lead to significant clinical consequences, including the misdiagnosis of amyloid pathology or the requirement for further invasive testing based on false-positive or indeterminate data.

Source

Information provided by the FDA.