Fujirebio Diagnostics Recalls Lumipulse G Beta-Amyloid 1-42-N Plasma Calibrators Due to Inaccurate Test Results
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Fujirebio Diagnostics, Inc. is recalling 128 units of Alzheimer's diagnostic calibrators that may provide 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.
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What Happened
Fujirebio Diagnostics, Inc. has initiated a voluntary Class II recall of its Lumipulse G β-Amyloid 1-42-N Plasma Calibrators. The recall was prompted by the discovery that customers may experience inaccurate test results. Specifically, the product may produce a higher frequency of classifications in the indeterminate and positive zones, or show low specificity compared to FDA-cleared CSF ratio/PET imaging. This is due to falsely elevated positive or indeterminate ratio results.
Which Products Are Affected
The recall affects 128 units distributed nationwide across 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 Calibrators
- Model/Catalog Number: 235454
- UDI-DI: 04987270235454
- Lot Numbers: D8C6022U, D8C6044U
- Components: Liquid (Frozen), 1 x 1.5 mL (4 Concentrations: CAL 1, CAL 2, CAL 3, CAL 4)
What You Should Do
Fujirebio Diagnostics, Inc. notified affected customers via letter on December 11, 2025. Facilities and laboratories using these calibrators should immediately check their inventory for the specified lot numbers (D8C6022U and D8C6044U). If these lots are found, users should follow the instructions provided in the firm's notification letter regarding the handling of the affected product. For further inquiries, the recalling firm is located at 201 Great Valley Pkwy, Malvern, PA 19355-1308.
Why This Matters
Inaccurate results from these calibrators can lead to the incorrect classification of a patient as having amyloid pathology associated with Alzheimer’s disease. This may result in a false positive diagnosis or lead to patients undergoing additional, unnecessary clinical testing due to indeterminate results.
Source
This information is based on official recall data provided by the FDA under recall number Z-1306-2026.
Original source: FDA Official Notice ↗
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