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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Fujirebio Lumipulse G β-Amyloid 1-42-N Plasma Calibrators recalled for inaccurate Alzheimer's disease test results

Fujirebio
OTHERNationwide distribution

Stop using Fujirebio Lumipulse calibrators

Fujirebio Diagnostics is recalling calibrator kits (model 235454, specific lot numbers) used in a blood test for Alzheimer's disease risk. The calibrators may cause inaccurate results, falsely flagging patients as positive or indeterminate for amyloid pathology when they should not be, or missing cases that should be detected.

  • If your medical provider used this test kit, contact them immediately to discuss your results and whether retesting is needed.
  • Do not use lot numbers D8C6022U or D8C6044U of this product.
  • Healthcare facilities: check your inventory and stop using affected lots; consult Fujirebio for guidance on potentially affected patient results.
Hazard

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).

Sold states
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Affected count
128 units
Manufactured in
201 Great Valley Pkwy, N/A, Malvern, PA, United States
Products
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-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 Calibrators: Liquid (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. Preservative: 0.1% ProClin 950. Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1306-2026

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