Fujirebio Diagnostics Recalls Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Due to Inaccurate Results
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Fujirebio Diagnostics, Inc. has issued a voluntary recall for 1,569 units of Alzheimer's diagnostic cartridges that may produce falsely elevated positive or indeterminate results.
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 G pTau 217 Plasma Immunoreaction Cartridges. The recall was prompted by reports of inaccurate test results, where users observed a higher frequency of classification in the indeterminate and positive zones. These falsely elevated ratios can lead to an incorrect classification of a patient as having amyloid pathology associated with Alzheimer’s disease or result in unnecessary additional clinical testing when compared to FDA-cleared CSF ratio or PET imaging.
Which Products Are Affected
The recall affects 1,569 units of the following diagnostic product:
- Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
- Model/Catalog Number: 81550
- UDI-DI: 05414470815500
- Lot Numbers: D4C6028U, D4C6029U, D4C6051U, D4C6052U
- Recall Number: Z-1302-2026
Distribution was nationwide within the United States, specifically reaching the following states: Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, and Washington.
What You Should Do
The firm initiated the recall via a notification letter sent to affected customers. Laboratories and healthcare facilities possessing the specified lot numbers should follow the instructions provided in the firm's notification. For further inquiries regarding the return or replacement of these cartridges, contact Fujirebio Diagnostics, Inc. at their Malvern, Pennsylvania headquarters.
Why This Matters
This recall is significant because inaccurate diagnostic results can lead to the misdiagnosis of Alzheimer’s disease pathology, potentially causing patients to undergo further invasive testing or receive incorrect clinical management.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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