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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
2018-02-07Z-0640-2019Class IITerminatedRBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.Distribution: US Nationwide distribution in the states of IN, WA, NC, CA, GA, CO.clearance family
Regulatory clearances
  • 510(k)K152776Substantially equivalent (SESE) · 2016-05-27clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

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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