FDA-Device2026-02-11Class IIPROCESSING DEFECT

Fujirebio Lumipulse G pTau217/B-Amyloid plasma ratio test recalled for inaccurate Alzheimer's disease results

FALSE CLAIMSNationwide distributionMedical devices Pet

What this means

Fujirebio's Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test may produce inaccurate results that falsely suggest Alzheimer's disease or incorrectly flag patients for additional testing. The test can show higher-than-actual ratios, leading to wrong patient classifications compared to confirmed imaging or cerebrospinal fluid tests.

If you work at a clinical or diagnostic lab, contact Fujirebio immediately about affected equipment (Model CL0073)
Ask your healthcare provider or lab if your recent Alzheimer's disease screening used this test
Discuss retesting with your doctor if you received unclear or positive results from this test

The agency's original wording

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).

Intended for

Adults

Illnesses reported

None reported

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

23 units

Manufactured in

201 Great Valley Pkwy, N/A, Malvern, PA, United States

Products

Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse ¿-Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454 Component: No

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1301-2026

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering pet owners — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.