Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number...
FDA Device Recall #Z-1305-2026 — Class II — December 11, 2025
Recall Summary
| Recall Number | Z-1305-2026 |
| 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 | 1423 units |
Product Description
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G ¿-Amyloid 1-42-N Plasma IRC), for the quantitative measurement of ¿-Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System. Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-¿-amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-¿-amyloid 1-42 monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
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: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;
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-1301-2026 | Class II | Product Name: Lumipulse G pTau217/B-Amyloid 1-4... | Dec 11, 2025 |
| Z-1307-2026 | Class II | Product Name: Lumipulse ¿-Amyloid Plasma Contro... | 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.