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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K242706
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Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Softwar... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 So... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse ®-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: No... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G ®-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 2... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G ®-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Softwar... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
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