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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
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-03-11Z-1696-2024Class IIOpen, ClassifiedSystem error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, France, Germany, Iceland, Netherlands, South Korea, Spain, Switzerland, Taiwan.58 unitscode info di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2017-08-04VAIVoluntary action indicatedAdvanced Instruments, LLC4
2017-08-04VAIVoluntary action indicatedAdvanced Instruments, LLC4
2012-02-07VAIVoluntary action indicatedAdvanced Instruments, LLC4
2012-02-07VAIVoluntary action indicatedAdvanced Instruments, LLC4
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