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

Lumipulse G pTau 217 Plasma Calibrators recalled

Fujirebio Diagnostics is recalling Lumipulse G pTau 217 Plasma Calibrators, 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: 81557; UDI-DI: 05414470815579; Lot Numbers: D5C6094U, D5C6125U;

Quantity recalled117 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-1303-2026
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: Medical Software

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 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

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: 81557; UDI-DI: 05414470815579; Lot Numbers: D5C6094U, D5C6125U;

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 pTau217/B-Amyloid 1-42 Plasma Ratio 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 pTau217/B-Amyloid 1-42 Plasma Ratio recalled	Fujirebio Diagnostics	Labeling Errors	Nationwide

Other Medical Software recalls

All 932

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Device Malfunction	CA
14 Oct 2026Device	CLASS II	Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems	Philips Medical Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide