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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
2026-03-30VAIVoluntary action indicatedAnalytical Control Systems, Inc8
2026-03-30VAIVoluntary action indicatedAnalytical Control Systems, Inc8
2019-12-19VAIVoluntary action indicatedAnalytical Control Systems, Inc4
2019-12-19VAIVoluntary action indicatedAnalytical Control Systems, Inc4
2016-09-30VAIVoluntary action indicatedAnalytical Control Systems, Inc0
2016-09-30VAIVoluntary action indicatedAnalytical Control Systems, Inc0
2016-02-29OAIOfficial action indicatedAnalytical Control Systems, Inc8
2016-02-29OAIOfficial action indicatedAnalytical Control Systems, Inc8
2014-05-08WLWarning LetterAnalytical Control Systems, Inc—
2014-05-08WLWarning LetterAnalytical Control Systems, Inc—
2013-12-03OAIOfficial action indicatedAnalytical Control Systems, Inc12
2013-12-03OAIOfficial action indicatedAnalytical Control Systems, Inc12
2010-03-22VAIVoluntary action indicatedAnalytical Control Systems, Inc3
2010-03-22VAIVoluntary action indicatedAnalytical Control Systems, Inc3
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