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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
2025-07-01NAINo action indicatedSYSMEX AMERICA - Vernon Hills0
2023-03-02NAINo action indicatedSysmex America, Inc.0
2018-01-31NAINo action indicatedSysmex America, Inc.0
2017-04-20VAIVoluntary action indicatedSysmex RA Co., LTD5
2016-12-08VAIVoluntary action indicatedSysmex Corporation1
2016-12-08VAIVoluntary action indicatedSysmex Corporation1
2016-09-16VAIVoluntary action indicatedSYSMEX CORPORATION I-SQUARE2
2016-06-07VAIVoluntary action indicatedSysmex Reagents America, Inc.1
2014-06-05NAINo action indicatedSysmex America Inc0
2013-01-17VAIVoluntary action indicatedSysmex Corporation2
2013-01-17VAIVoluntary action indicatedSysmex Corporation2
2012-02-06VAIVoluntary action indicatedSysmex Reagents America, Inc.1
2012-02-06VAIVoluntary action indicatedSysmex America, Inc.6
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