Home › Fujirebio Diagnostics, Inc. › Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Fujirebio Diagnostics, Inc. · Model CL0073 · UDI-DI 00869164000086
1
510(k) clearances
0
Adverse events
7
Recalls
4
Facilities
Description
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-11 | Fujirebio 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 |
| 2025-12-11 | Fujirebio 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 |
| 2025-12-11 | Fujirebio 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 |
| 2025-12-11 | Fujirebio 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 |
| 2025-12-11 | Fujirebio 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 |
| 2025-12-11 | Fujirebio 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 |
| 2025-12-11 | Fujirebio 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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Get your free API keyRead the docsData 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.