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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Fujirebio Lumipulse G β-Amyloid 1-42 plasma test cartridges recalled for inaccurate Alzheimer's disease results

Fujirebio
FALSE CLAIMSNationwide distribution

Stop using Fujirebio Lumipulse G amyloid test cartridges

Fujirebio Diagnostics is recalling Lumipulse G β-Amyloid 1-42 Plasma test cartridges (Model 235447, certain lot numbers) because they may produce falsely high or falsely indeterminate results. This could incorrectly classify patients as having Alzheimer's disease pathology or unnecessarily recommend further testing. Healthcare providers should stop using affected cartridges immediately.

  • Check if your facility received cartridges with lot numbers C5C6022U or C5C6045U
  • Stop using affected cartridges right away
  • Review any test results from these cartridges in your medical records
  • Contact your healthcare provider if you received an Alzheimer's disease diagnosis using this test
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).

Sold states
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Affected count
1423 units
Manufactured in
201 Great Valley Pkwy, N/A, Malvern, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1305-2026

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