Fujirebio Diagnostics, Inc.
Malvern, PA
This page shows every FDA and USDA recall linked to Fujirebio Diagnostics, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
8
Total Recalls
2010
First Recall
2026
Most Recent
Product Name: Lumipulse pTau 217 Plasma Controls
Model/Catalog Number: 81558
Software Version: Not Applicable...
Feb 5, 2026
· Device
Open, Classified
Product Name: Lumipulse G pTau 217 Plasma Calibrators
Model/Catalog Number: 81557
Software Version: Not Applic...
Feb 5, 2026
· Device
Open, Classified
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Model/Catalog Number: CL0073
Software Version: N...
Feb 5, 2026
· Device
Open, Classified
Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges
Model/Catalog Number: 235447
Softwa...
Feb 5, 2026
· Device
Open, Classified
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
Model/Catalog Number: 81550
Software Versi...
Feb 5, 2026
· Device
Open, Classified
Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators
Model/Catalog Number: 235454
Software Version: No...
Feb 5, 2026
· Device
Open, Classified
Product Name: Lumipulse -Amyloid Plasma Controls
Model/Catalog Number: 81559
Software Version: Not Applicable...
Feb 5, 2026
· Device
Open, Classified
MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed...
Mar 8, 2011
· Device
Terminated