Fujirebio Diagnostics Recalls Lumipulse pTau 217 Plasma Controls Over Inaccurate Alzheimer's Test Results
Fujirebio Diagnostics, Inc. is recalling 148 units of Lumipulse pTau 217 Plasma Controls due to a defect that may cause falsely elevated results in Alzheimer's disease testing.
What Happened
Fujirebio Diagnostics, Inc. has initiated a voluntary recall of its Lumipulse pTau 217 Plasma Controls. The company determined that users may experience inaccurate test results, characterized by a higher frequency of classifications in the “indeterminate” and “positive” zones. This issue is caused by falsely elevated positive or indeterminate ratio results when compared to FDA-cleared CSF ratio or PET imaging.
Which Products Are Affected
The recall affects 148 units of the following diagnostic medical device:
- Product Name: Lumipulse pTau 217 Plasma Controls
- Model/Catalog Number: 81558
- UDI-DI: 05414470815586
- Lot Numbers: D6C6092U, D6C6092U1, D6C6123U
Distribution Area: The affected products were distributed 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 a formal letter initiated on December 11, 2025. Laboratories and clinical facilities using these controls should immediately check their inventory for the specified lot numbers. If affected products are found, users should follow the instructions provided in the firm’s notification letter regarding the handling and disposal or return of the units.
Why This Matters
The defect is significant because it can lead to the incorrect classification of a patient as having amyloid pathology associated with Alzheimer’s disease. Additionally, these inaccurate results may cause patients to undergo unnecessary clinical testing due to false indeterminate results.
Source
Information provided by the FDA under Recall Number Z-1304-2026.
Source: FDA Official Notice