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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
2025-09-09NAINo action indicatedDiagnostica Stago, Inc.0
2025-09-09NAINo action indicatedDiagnostica Stago, Inc.0
2024-09-04VAIVoluntary action indicatedDiagnostica Stago, Inc.1
2024-09-04VAIVoluntary action indicatedDiagnostica Stago, Inc.1
2018-04-12NAINo action indicatedDiagnostica Stago0
2018-04-10NAINo action indicatedDiagnostica Stago0
2018-04-10NAINo action indicatedDiagnostica Stago0
2013-11-08VAIVoluntary action indicatedDiagnostica Stago, Inc.4
2013-11-08VAIVoluntary action indicatedDiagnostica Stago, Inc.4
2011-07-07VAIVoluntary action indicatedDiagnostica Stago2
2011-07-07VAIVoluntary action indicatedDiagnostica Stago - Taverny Site1
2011-07-05NAINo action indicatedDiagnostica Stago0
2011-07-05NAINo action indicatedDiagnostica Stago0
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