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 |
|---|---|---|---|---|
| 2016-12-15 | VAI | Voluntary action indicated | Microgenics Corporation | 1 |
| 2015-07-16 | NAI | No action indicated | Microgenics Corporation | 0 |
| 2014-10-20 | VAI | Voluntary action indicated | Microgenics Corporation | 1 |
| 2013-10-25 | NAI | No action indicated | Microgenics Corporation | 0 |
| 2013-10-25 | NAI | No action indicated | Microgenics Corporation | 0 |
| 2012-06-14 | VAI | Voluntary action indicated | Microgenics Corporation | 0 |
| 2012-06-14 | VAI | Voluntary action indicated | Microgenics Corporation | 2 |
| 2010-06-02 | NAI | No action indicated | Microgenics Corporation | 0 |
| 2010-01-28 | NAI | No action indicated | Microgenics Corporation | 0 |
Similar devices
- ADVIA Centaur® CARB Siemens Healthcare Diagnostics Inc.
- ADVIA Centaur® CARB +Z Siemens Healthcare Diagnostics Inc.
- ADVIA Centaur® CARB MCM Siemens Healthcare Diagnostics Inc.
- ADVIA® Chemistry CARB_2 Reagents Siemens Healthcare Diagnostics Inc.
- ARCHITECT Abbott GmbH
- ARCHITECT Abbott GmbH
- ARCHITECT Abbott GmbH
- ARCHITECT ABBOTT LABORATORIES
- Alinity ABBOTT LABORATORIES
- Atellica CH Carb Siemens Healthcare Diagnostics Inc.
- CBZ RANDOX LABORATORIES LIMITED
- Carbamazepine Roche Diagnostics GmbH
Select up to two to place side-by-side with this device.