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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-1301-2026 - Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/®-Amyloid 1-42 Plasma Ratio is a... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Z-1302-2026 - Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cart... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Z-1303-2026 - Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Z-1307-2026 - Product Name: Lumipulse ®-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ®-Amyloid Plasma Controls: This quality control produc... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Z-1305-2026 - Product Name: Lumipulse G ®-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ®-Amyloid 1-42-N Plasma Im... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Z-1306-2026 - Product Name: Lumipulse G ®-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ®-Amyloid 1-42-N Plasma Calibrators: Th... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
Z-1304-2026 - Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product ... 2 02/05/2026 FEI # 2521625
Fujirebio Diagnostics, Inc.
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