Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 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-phosphorylated Tau (217) 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-Tau monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
- Company
- Fujirebio Diagnostics, Inc.
- Recall Initiated
- December 11, 2025
- Posted
- February 5, 2026
- Recall Number
- Z-1302-2026
- Quantity
- 1569 units
- Firm Location
- Malvern, PA
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).
Distribution
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Lot / Code Info
Model/Catalog Number: 81550; UDI-DI: 05414470815500; Lot Numbers: D4C6028U, D4C6029U, D4C6051U, D4C6052U;
Root 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.