MAUDE brand profile

ELECSYS FT4 II ASSAY

MAUDE brand safety profile

Key facts

Brand name ELECSYS FT4 II ASSAY

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • High Test Results, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Incorrect Or Inadequate Test Results, Low Test Results, Non Reproducible Results, No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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