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Fujirebio Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
45
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1301-2026Class IIProduct Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 SoftwarDecember 11, 2025
Z-1303-2026Class IIProduct Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software VersionDecember 11, 2025
Z-1302-2026Class IIProduct Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 SoDecember 11, 2025
Z-1307-2026Class IIProduct Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: NoDecember 11, 2025
Z-1306-2026Class IIProduct Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 SoftwarDecember 11, 2025
Z-1304-2026Class IIProduct Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: NotDecember 11, 2025
Z-1305-2026Class IIProduct Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 2December 11, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K250925ADVIA Centaur Cytokeratin Fragment 21-1December 16, 2025
K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioMay 16, 2025
DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)May 4, 2022
K192524Lumipulse G CA15-3September 4, 2020
K192380ST AIA-PACK BNPAugust 24, 2020
K200997Lumipulse G CA19-9-NMay 14, 2020
K190702Lumipulse G whole PTHAugust 30, 2019
K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setDecember 10, 2017
K171103Lumipulse G TSH-III Immunoreaction CartridgesJuly 28, 2017
K163534Lumipulse G FSH-N CalibratorsJanuary 13, 2017
K163546Lumipulse G Progesterone-N CalibratorsJanuary 13, 2017
K163544Lumipulse G ProlactinJanuary 12, 2017
K163521Lumipulse G LH CalibratorsJanuary 12, 2017
K163053Lumipulse G E2-III CalibratorsDecember 1, 2016
K153145Lumipulse G TP-N Immunoreaction Cartridge SetJuly 5, 2016
K160090Lumipulse G ROMAMay 16, 2016
K151502ARCHITECT ROMAApril 28, 2016
K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsApril 15, 2016
K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsNovember 24, 2015
K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II CalibraMay 21, 2015