Class 2 Device Recall Lumipulse G pTau217/BAmyloid 142 Plasma Ratio

• Date Initiated by Firm: December 11, 2025
• Date Posted: February 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1302-2026
• Recall Event ID: 98232
• 510(K)Number: K242706
• Product Classification: Immunoassay blood test for amyloid pathology assessment - Product Code SET
• Product: 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
• Code Information: Model/Catalog Number: 81550; UDI-DI: 05414470815500; Lot Numbers: D4C6028U, D4C6029U, D4C6051U, D4C6052U
• FEI Number: 2521625
• Recalling Firm/ Manufacturer: Fujirebio Diagnostics, Inc.; 201 Great Valley Pkwy; Malvern PA 19355-1308
• For Additional Information Contact: Gregory Dickson; 1-610-2403888
• Manufacturer 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: 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.
• Quantity in Commerce: 1569 units
• Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = SET