Recall Z-1301-2026
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 pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G -Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse -Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G -Amyloid 1-42-N Plasma Calibrators set 235454 Component: No
Codes / lots: Model/Catalog Number: CL0073; UDI-DI: 00869164000086; Distribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio ("Ratio") is related to the "Ratio" Instructions for Use (IFU). Therefore, each consignee has 1 "Ratio" in which they purchase the component kits for.
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-1301-2026
- Initiated
- December 11, 2025
- Posted by FDA
- February 5, 2026
- Product code
- SET – Immunoassay Blood Test For Amyloid Pathology Assessment
- Quantity
- 23 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-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-1305-2026 Class II | Product Name: Lumipulse G -Amyloid 1-42-N 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-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 |