MAUDE manufacturer profile

ORTHO-CLINICAL DIAGNOSTICS, INC. · KHO

MAUDE profile for Fluorometer, For Clinical Use

Key facts

Manufacturer ORTHO-CLINICAL DIAGNOSTICS, INC.
Manufacturer group ORTHO-CLINICAL DIAGNOSTICS, INC.
Product code KHO
Product code name Fluorometer, For Clinical Use

At a glance

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

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

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

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

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