Fujirebio Diagnostics, Inc.: Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreact

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Fujirebio Diagnostics, Inc.
Product: 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 / hazard: 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).
Classification: Class II
Status: Ongoing
Distribution / sold at: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Recall initiated: 2025-12-11
Code info: Model/Catalog Number: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;
Product quantity: 1423 units
Voluntary mandated: Voluntary: Firm initiated
City: Malvern
State: PA
Country: United States
Event id: 98232

Fujirebio Diagnostics, Inc.: Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable