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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
DateTypeOutcomeFacilityCitations
2023-11-30NAINo action indicatedRoche Molecular Systems, Inc.0
2022-12-07NAINo action indicatedRoche Diagnostics Operations, Inc.0
2022-09-23NAINo action indicatedVentana Medical Systems, Inc.0
2022-09-15NAINo action indicatedVentana Medical Systems, Inc.0
2021-07-29NAINo action indicatedVentana Medical Systems, Inc.0
2020-02-26NAINo action indicatedVentana Medical Systems, Inc.0
2019-08-29VAIVoluntary action indicatedRoche Diagnostics GmbH0
2019-08-14NAINo action indicatedVentana Medical Systems, Inc.0
2019-07-25VAIVoluntary action indicatedRoche Diabetes Care, Inc.3
2019-06-27VAIVoluntary action indicatedRoche Diagnostics Operations, Inc.1
2018-04-19NAINo action indicatedRoche Diagnostics GmbH0
2018-04-12NAINo action indicatedRoche Diagnostics GmbH0
2017-07-24NAINo action indicatedRoche Molecular Systems, Inc.0
2017-07-13NAINo action indicatedVentana Medical Systems, Inc.0
2017-02-27NAINo action indicatedRoche Molecular Systems, Inc.0
2017-02-02VAIVoluntary action indicatedRoche Diabetes Care GmbH1
2016-11-18NAINo action indicatedRoche Diagnostics GmbH0
2016-10-14NAINo action indicatedRoche Diagnostics Operations, Inc.0
2016-09-01NAINo action indicatedRoche Molecular Systems, Inc.0
2016-08-15VAIVoluntary action indicatedRoche Diagnostics Operations, Inc.1
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