Fujirebio Diagnostics Recalls Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Test Due to Inaccurate Results
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Fujirebio Diagnostics, Inc. has issued a voluntary recall for its Lumipulse G diagnostic test ratio due to potential for falsely elevated results that may lead to incorrect Alzheimer's disease classification.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 18, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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What Happened
Fujirebio Diagnostics, Inc. has initiated a voluntary recall of the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio diagnostic test. The company identified that customers may experience inaccurate test results, specifically a higher frequency of indeterminate or positive classifications and low specificity when compared to FDA-cleared CSF ratio or PET imaging. This issue is caused by falsely elevated positive or indeterminate ratio results, which can lead to a patient being incorrectly classified as having amyloid pathology associated with Alzheimer’s disease or requiring unnecessary additional clinical testing.
Which Products Are Affected
The recall affects the following diagnostic product and its associated components:
- Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
- Model/Catalog Number: CL0073
- UDI-DI: 00869164000086
- Recall Number: Z-1301-2026
- Quantity: 23 units
- Affected Components: The recall involves several imported kits, including Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (81550), Calibrators (81557), and Controls (81558), as well as Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges (235447), Calibrators (235454), and Controls (81559).
Distribution Area: The affected units were distributed nationwide in 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 consignees via an initial firm notification letter sent on December 11, 2025. Laboratory professionals and healthcare providers using this diagnostic ratio should follow the instructions provided in the firm's notification. For further information regarding returns or technical guidance, contact Fujirebio Diagnostics, Inc. at their Malvern, PA location.
Why This Matters
This recall is significant because inaccurate diagnostic results can lead to the misdiagnosis of amyloid pathology associated with Alzheimer's disease. Such errors may result in patients undergoing unnecessary medical procedures or receiving incorrect clinical management based on false-positive or indeterminate test outcomes.
Source
Information provided by the FDA under recall number Z-1301-2026.
Original source: FDA Official Notice ↗
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