Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Soft...
FDA Device Recall #Z-1301-2026 — Class II — December 11, 2025
Recall Summary
| Recall Number | Z-1301-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 11, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fujirebio Diagnostics, Inc. |
| Location | Malvern, PA |
| Product Type | Devices |
| Quantity | 23 units |
Product Description
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
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).
Distribution Pattern
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Lot / Code Information
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.
Other Recalls from Fujirebio Diagnostics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1304-2026 | Class II | Product Name: Lumipulse pTau 217 Plasma Control... | Dec 11, 2025 |
| Z-1303-2026 | Class II | Product Name: Lumipulse G pTau 217 Plasma Calib... | Dec 11, 2025 |
| Z-1307-2026 | Class II | Product Name: Lumipulse ¿-Amyloid Plasma Contro... | Dec 11, 2025 |
| Z-1305-2026 | Class II | Product Name: Lumipulse G ¿-Amyloid 1-42-N Plas... | Dec 11, 2025 |
| Z-1306-2026 | Class II | Product Name: Lumipulse G ¿-Amyloid 1-42-N Plas... | Dec 11, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.