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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
2023-05-24Z-0783-2024Class IIOpen, ClassifiedComplaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.Distribution: US Nationwide.124,928 kitsclearance family
Regulatory clearances
  • 510(k)K173792Substantially equivalent (SESE) · 2018-03-13clearance family
  • 510(k)K140225Substantially equivalent (SESE) · 2014-10-27clearance family

Predicate lineage

Cited as predicate by: K173792, K182774

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
2013-11-21NAINo action indicatedPhadia GmbH0
2011-08-18NAINo action indicatedPhadia Ab0
2011-08-18NAINo action indicatedPhadia Ab0
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