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-1307-2026
• Recall Event ID: 98232
• 510(K)Number: K242706
• Product Classification: Immunoassay blood test for amyloid pathology assessment - Product Code SET
• Product: Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse -Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing -amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse -Amyloid Plasma Controls: Liquid (Frozen), 2 2 Concentrations L1 Level 1 (2 1.5 mL) L2 Level 2 (2 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
• Code Information: Model/Catalog Number: 81559; UDI-DI: 05414470815593; Lot Number: T8B6116U
• 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: 179 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