MAUDE manufacturer profile

ROCHE DIAGNOSTICS · DDR

MAUDE profile for Myoglobin, Antigen, Antiserum, Control

Key facts

Manufacturer ROCHE DIAGNOSTICS
Manufacturer group ROCHE DIAGNOSTICS GMBH
Product code DDR
Product code name Myoglobin, Antigen, Antiserum, Control

At a glance

  • 10–99 MAUDE reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Low Test Results, No Consequences Or Impact To Patient, High Test Results, Non Reproducible Results, No Known Impact Or Consequence To Patient, False Negative Result, 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 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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