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
- 510(k)K170678Substantially equivalent (SESE) · 2017-04-04clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-08-29 | VAI | Voluntary action indicated | Roche Diagnostics GmbH | 0 |
| 2018-04-19 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2018-04-12 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2016-11-18 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2015-05-27 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2015-05-20 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2013-12-18 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2012-09-27 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2012-09-20 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2011-02-17 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2011-02-15 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
| 2011-02-10 | NAI | No action indicated | Roche Diagnostics GmbH | 0 |
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