CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report

Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio recalled

Fujirebio Diagnostics is recalling Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio, distributed nationwide in the US. The recall was initiated on 11 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: CL0073; UDI-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.

Quantity recalled23 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1301-2026
FDA event ID: 98232
Recalling firm: Fujirebio Diagnostics, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Dec 2025
FDA classified: 5 Feb 2026
Reported: 11 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Test Kits & Diagnostics

Timeline

11 Dec 2025	Recall initiated by company
5 Feb 2026	Classified by FDA	+56 days
11 Feb 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Arizona California Florida Indiana Kansas Kentucky Massachusetts Maryland Minnesota New Jersey Pennsylvania Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Model/Catalog Number: CL0073; UDI-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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 98232

This product is part of a recall event; the main page for the event is Lumipulse pTau 217 Plasma Controls recalled by Fujirebio Diagnostics.

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026	CLASS II	Lumipulse pTau 217 Plasma Controls recalled by Fujirebio Diagnostics	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Lumipulse G pTau 217 Plasma Calibrators recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Lumipulse ¿-Amyloid Plasma Controls recalled by Fujirebio Diagnostics	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Lumipulse G pTau 217 Plasma Immunoreaction Cartridges recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide

More recalls from Fujirebio Diagnostics

All 7

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Device	CLASS II	Lumipulse G pTau 217 Plasma Immunoreaction Cartridges recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse ¿-Amyloid Plasma Controls recalled by Fujirebio Diagnostics	Fujirebio Diagnostics	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Lumipulse G pTau 217 Plasma Calibrators recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide

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