Fujirebio Diagnostics, Inc.: Product Name: Lumipulse pTau 217 Plasma Controls Model/Catal

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Fujirebio Diagnostics, Inc.
Product: Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 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 pTau 217 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 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Reason / hazard: 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).
Classification: Class II
Status: Ongoing
Distribution / sold at: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Recall initiated: 2025-12-11
Code info: Model/Catalog Number: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;
Product quantity: 148 units
Voluntary mandated: Voluntary: Firm initiated
City: Malvern
State: PA
Country: United States
Event id: 98232

Fujirebio Diagnostics, Inc.: Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipu