Fujirebio Diagnostics Recalls Lumipulse G β-Amyloid 1-42-N Plasma Test Cartridges for Inaccurate Results
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Fujirebio Diagnostics is recalling 1,423 units of Alzheimer's diagnostic cartridges due to potential falsely elevated positive results that may lead to incorrect patient classification.
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 β-Amyloid 1-42-N Plasma Immunoreaction Cartridges. The company identified a defect where customers may experience inaccurate test results, specifically observing a higher frequency of classifications in the indeterminate and positive zones. This issue results in low specificity when compared to FDA-cleared CSF ratio or PET imaging, potentially causing a patient to be incorrectly classified as having amyloid pathology associated with Alzheimer’s disease or requiring unnecessary additional clinical testing.
Which Products Are Affected
The recall involves 1,423 units distributed nationwide in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, and Washington.
- Product Name: Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC)
- Model/Catalog Number: 235447
- UDI-DI: 04987270235447
- Lot Numbers: C5C6022U, C5C6045U
- Recall Number: Z-1305-2026
What You Should Do
Fujirebio Diagnostics, Inc. began notifying customers via letter on December 11, 2025. Laboratories and healthcare providers in possession of the affected lot numbers (C5C6022U and C5C6045U) should immediately follow the instructions provided in the firm's notification letter regarding the use and handling of these cartridges. For further information, consumers may contact Fujirebio Diagnostics, Inc. at their Malvern, Pennsylvania headquarters.
Why This Matters
This recall is significant because falsely elevated positive or indeterminate results can lead to the misdiagnosis of Alzheimer’s-related pathology, potentially resulting in inappropriate clinical management or the pursuit of unnecessary medical procedures for patients.
Source
Information provided by the FDA (Recall Event ID: 98232).
Original source: FDA Official Notice ↗
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