Fujirebio Diagnostics Recalls Lumipulse pTau 217 Plasma Controls Over Inaccurate Alzheimer's Test Results
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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 this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
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.
Original source: FDA Official Notice ↗
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