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Lumipulse B-Amyloid Plasma Controls

Fujirebio Europe · Model 81559 · UDI-DI 05414470815593

SET Prescription
1
510(k) clearances
0
Adverse events
7
Recalls
4
Facilities

Description

Lumipulse B-Amyloid Plasma Controls 2x2C, IVD-US

Recalls

DateFirmReason
2025-12-11Fujirebio Diagnostics, Inc.Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back
2025-12-11Fujirebio Diagnostics, Inc.Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back
2025-12-11Fujirebio Diagnostics, Inc.Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back
2025-12-11Fujirebio Diagnostics, Inc.Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back
2025-12-11Fujirebio Diagnostics, Inc.Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back
2025-12-11Fujirebio Diagnostics, Inc.Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back
2025-12-11Fujirebio Diagnostics, Inc.Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.