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

Is Fujirebio Diagnostics recalled?

Fujirebio Diagnostics recalls - full list & free alerts

Official U.S. agency records list 7 recalls involving Fujirebio Diagnostics in the last 12 months, most recently on 2026-02-11. Check each official notice for the exact products, lot codes and dates affected.

Check a lot code, UPC or model number

This is not a guarantee; check the official notice.

Recalls (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
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