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 15C 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
FDA Recall Z-1305-2026 · Posted 2026-02-05
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Recalling FirmFujirebio Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeSET
Date Initiated2025-12-11
Product Quantity1423 units
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).
Firm Action
On or about December 11, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. Actions to be taken:
- Immediately discontinue using the associated Lots listed above for the Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio.
- Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
- Notify your ordering physician or health care provider as appropriate.
- The test results must be interpreted in conjunction with other diagnostic tools and clinical information.
- Please retain this letter with your laboratory records and forward this leer to those who may have received this product.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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