MAUDE manufacturer profile

ORTHO-CLINICAL DIAGNOSTICS, INC. · JIX

MAUDE profile for Calibrator, Multi-Analyte Mixture

Key facts

Manufacturer ORTHO-CLINICAL DIAGNOSTICS, INC.
Manufacturer group ORTHO-CLINICAL DIAGNOSTICS, INC.
Product code JIX
Product code name Calibrator, Multi-Analyte Mixture

At a glance

  • 100–999 MAUDE reports
  • 100–999 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • High Test Results, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Low Test Results, No Consequences Or Impact To Patient, High Readings, Incorrect, Inadequate or Imprecise Result or Readings, No Device Output 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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