Home › Roche Diagnostics GmbH › Elecsys Phospho-Tau (181P) Plasma
Elecsys Phospho-Tau (181P) Plasma
Roche Diagnostics GmbH · Model 09697870190 · UDI-DI 07613336216941
SET
Prescription
1
510(k) clearances
0
Adverse events
7
Recalls
4
Facilities
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.