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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
2025-12-11Z-1095-2026Class IIOpen, ClassifiedPotential for microbial contamination.Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.7,720 unitsclearance family
Regulatory clearances

    Predicate lineage

    K060688

    Cited as predicate by: K150877

    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
    2017-04-19VAIVoluntary action indicatedInstrumentation Lab Co2
    2013-07-12VAIVoluntary action indicatedInstrumentation Laboratory0
    2013-07-12VAIVoluntary action indicatedInstrumentation Laboratory0
    2013-02-27VAIVoluntary action indicatedInstrumentation Lab Co8
    2011-08-24VAIVoluntary action indicatedInstrumentation Laboratory5
    2011-08-24VAIVoluntary action indicatedInstrumentation Laboratory5
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