MAUDE manufacturer profile

ORTHO CLINICAL DIAGNOSTICS · QHR

MAUDE profile for Blood Grouping Reagent

Key facts

Manufacturer ORTHO CLINICAL DIAGNOSTICS
Manufacturer group ORTHO CLINICAL DIAGNOSTICS
Product code QHR
Product code name Blood Grouping Reagent

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Improper or Incorrect Procedure or Method, False Positive Result, False Negative Result, Incorrect, Inadequate or Imprecise Result or Readings, Laceration(s), Insufficient Information 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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