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
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-06-28 | NAI | No action indicated | Sebia, Inc. | 0 |
| 2015-01-29 | NAI | No action indicated | Interlab S.r.l. | 0 |
| 2013-02-28 | WL | Warning Letter | Interlab S.r.l. | — |
| 2012-10-25 | OAI | Official action indicated | Interlab S.r.l. | 6 |
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