Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- De NovoDEN170029De Novo granted (DENG) · 2018-03-19 · +1 earlier decisionsclearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-02-27 | WL | Warning Letter | Longhorn Vaccines And Diagnostics LLC | — |
| 2026-02-27 | WL | Warning Letter | Longhorn Vaccines And Diagnostics LLC | — |
| 2025-10-30 | OAI | Official action indicated | Longhorn Vaccines And Diagnostics LLC | 2 |
| 2025-10-30 | OAI | Official action indicated | Longhorn Vaccines And Diagnostics LLC | 2 |
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