MAUDE manufacturer profile

BECTON, DICKINSON & CO. (SPARKS) · NJR

MAUDE profile for Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Key facts

Manufacturer BECTON, DICKINSON & CO. (SPARKS)
Manufacturer group BECTON, DICKINSON & CO. (SPARKS)
Product code NJR
Product code name Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • False Positive Result, No Clinical Signs, Symptoms or Conditions, Insufficient Information, 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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