Reported Feb 11, 2026 · Ongoing
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 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 pTau217/B-Amyloid 1-42
- Plasma Ratio Model/Catalog NumberCL0073
- Software VersionNot
- Applicable Product DescriptionLumipulse 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 importedKit 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 ComponentNo
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published CL0073Model/ — 00869164000086UDI-DI: 00869164000086 — Distribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio ("Ratio") is related to the "Ratio" Instructions for Use (IFU). Therefore, each consignee has 1 "Ratio" in which they purchase the component kits for. - Amount recalled
- 23 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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