Fujirebio Diagnostics, Inc. recalls Product Name: Lumipulse G pTau 217 Plasma Calibrators

Recalling company

Fujirebio Diagnostics, Inc.

Product

Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Reason

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).

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Dec 11, 2025

Reported

Feb 11, 2026

Distribution

US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.

Status

Ongoing

Quantity

117 units

Lot / codes

Model/Catalog Number: 81557; UDI-DI: 05414470815579; Lot Numbers: D5C6094U, D5C6125U;

Company location

Malvern, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-1303-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1303-2026 in the FDA Enforcement Report. Also see FDA recall press releases.