Reported Feb 11, 2026 · Ongoing
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not…
Fujirebio Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujirebio Diagnostics, Inc. · 201 Great Valley Pkwy · Malvern, PA · 19355-1308
Is this the product you have?
- Product NameLumipulse G ¿-Amyloid 1-42-N
- Plasma Calibrators Model/Catalog Number235454
- Software VersionNot
- Applicable Product DescriptionLumipulse G ¿-Amyloid 1-42-N
- Plasma CalibratorsThe ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G ¿-Amyloid 1-42-N
- Plasma CalibratorsLiquid (Frozen), 1 ¿ 1.5 mL (4 Concentrations) CAL 1 0 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers
- Preservative0.1% ProClin 950
- ComponentYes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
- Lot codes and dates
- Model/Catalog Number235454
- UDI-DI04987270235454
- Lot Numbers
D8C6022UD8C6044U
- Amount recalled
- 128 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
This product could cause temporary or reversible health problems — stop using it.
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