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Fujirebio Diagnostics, Inc. FDA Recalls

7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable PrClass IIDec 11, 2025Customers may experience inaccurate test results by observin	Customers may experience inaccurate test results by observing a higher frequency of classification in the inde	Class IIDevices	Dec 11, 2025
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not AppliClass IIDec 11, 2025Customers may experience inaccurate test results by observin	Customers may experience inaccurate test results by observing a higher frequency of classification in the inde	Class IIDevices	Dec 11, 2025
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software VersClass IIDec 11, 2025Customers may experience inaccurate test results by observin	Customers may experience inaccurate test results by observing a higher frequency of classification in the inde	Class IIDevices	Dec 11, 2025
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not AppliClass IIDec 11, 2025Customers may experience inaccurate test results by observin	Customers may experience inaccurate test results by observing a higher frequency of classification in the inde	Class IIDevices	Dec 11, 2025
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable ProductClass IIDec 11, 2025Customers may experience inaccurate test results by observin	Customers may experience inaccurate test results by observing a higher frequency of classification in the inde	Class IIDevices	Dec 11, 2025
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable ProducClass IIDec 11, 2025Customers may experience inaccurate test results by observin	Customers may experience inaccurate test results by observing a higher frequency of classification in the inde	Class IIDevices	Dec 11, 2025
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Class IIDec 11, 2025Customers may experience inaccurate test results by observin	Customers may experience inaccurate test results by observing a higher frequency of classification in the inde	Class IIDevices	Dec 11, 2025

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