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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
2020-12-14Z-1107-2021Class IITerminatedDecreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).Distribution: US Nationwide distribution.365 kits UScode info di
Regulatory clearances

    Predicate lineage

    K072393

    Cited as predicate by: K253367

    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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