MAUDE manufacturer profile

BECTON, DICKINSON & CO. (SPARKS) · QKP

MAUDE profile for Coronavirus Antigen Detection Test System.

Key facts

Manufacturer BECTON, DICKINSON & CO. (SPARKS)
Manufacturer group BECTON, DICKINSON & CO. (SPARKS)
Product code QKP
Product code name Coronavirus Antigen Detection Test System.

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Incorrect, Inadequate or Imprecise Result or Readings, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, False Negative Result, False Positive Result, No Information, Non Reproducible Results, Device Markings/Labelling 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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