⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Fujirebio Diagnostics recalls - full list & free alerts

7 official U.S. recalls involving Fujirebio Diagnostics in the last 12 months, most recently on 2026-02-11.

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Full list (7)

Fujirebio Diagnostics, Inc.: Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Descr
Medical DevicesFDA (device) · 2026-02-11 · Class II
Fujirebio Diagnostics, Inc.: Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product
Medical DevicesFDA (device) · 2026-02-11 · Class II
Fujirebio Diagnostics, Inc.: Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: L
Medical DevicesFDA (device) · 2026-02-11 · Class II
Fujirebio Diagnostics, Inc.: Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipu
Medical DevicesFDA (device) · 2026-02-11 · Class II
Fujirebio Diagnostics, Inc.: Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable
Medical DevicesFDA (device) · 2026-02-11 · Class II
Fujirebio Diagnostics, Inc.: Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Descr
Medical DevicesFDA (device) · 2026-02-11 · Class II
Fujirebio Diagnostics, Inc.: Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumip
Medical DevicesFDA (device) · 2026-02-11 · Class II