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Fujirebio Diagnostics, Inc.

8 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 recall (Z-1301-2026)Fujirebio Diagnostics, Inc.2026-02-05
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: recall (Z-1302-2026)Fujirebio Diagnostics, Inc.2026-02-05
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software recall (Z-1303-2026)Fujirebio Diagnostics, Inc.2026-02-05
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Vers recall (Z-1304-2026)Fujirebio Diagnostics, Inc.2026-02-05
Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog N recall (Z-1305-2026)Fujirebio Diagnostics, Inc.2026-02-05
Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 recall (Z-1306-2026)Fujirebio Diagnostics, Inc.2026-02-05
Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software Vers recall (Z-1307-2026)Fujirebio Diagnostics, Inc.2026-02-05
MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of recall (Z-1606-2011)Fujirebio Diagnostics, Inc.2011-03-08

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Every clearance here is in the API, with alerts when new ones post.