Fujirebio Diagnostics Recalls Lumipulse G pTau 217 Plasma Calibrators Due to Inaccurate Test Results
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Fujirebio Diagnostics, Inc. has recalled 117 units of Alzheimer's diagnostic calibrators due to potential for falsely elevated results that could lead to patient misclassification.
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.
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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.
Original source: FDA Official Notice ↗
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