Recall Z-1305-2026
Fujirebio Diagnostics, Inc. · initiated December 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 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
Codes / lots: Model/Catalog Number: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;
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).
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1305-2026
- Initiated
- December 11, 2025
- Posted by FDA
- February 5, 2026
- Product code
- SET – Immunoassay Blood Test For Amyloid Pathology Assessment
- Quantity
- 1423 units
- Distribution
- US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
- Recalling firm
- Fujirebio Diagnostics, Inc., Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1301-2026 Class II | Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number:…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1302-2026 Class II | Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1303-2026 Class II | Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1304-2026 Class II | Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1306-2026 Class II | Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number:…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |
| Z-1307-2026 Class II | Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software…Customers may experience inaccurate test results by observing a higher frequency of classification in the… | 12/11/2025Open, Classified |