MAUDE manufacturer profile

ORTHO-CLINICAL DIAGNOSTICS, INC. · JLW

MAUDE profile for Radioimmunoassay, Thyroid-Stimulating Hormone

Key facts

Manufacturer ORTHO-CLINICAL DIAGNOSTICS, INC.
Manufacturer group ORTHO-CLINICAL DIAGNOSTICS
Product code JLW
Product code name Radioimmunoassay, Thyroid-Stimulating Hormone

At a glance

  • 100–999 MAUDE reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Low Test Results, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, High Test Results, No Consequences Or Impact To Patient, Incorrect, Inadequate or Imprecise Result or Readings, Incorrect Or Inadequate Test Results, Adverse Event Without Identified Device or Use Problem 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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