MAUDE manufacturer profile

BECKMAN COULTER IRELAND INC · OYE

MAUDE profile for Flow Cytometric Reagents And Accessories.

Key facts

Manufacturer BECKMAN COULTER IRELAND INC
Manufacturer group BECKMAN COULTER, INC.
Product code OYE
Product code name Flow Cytometric Reagents And Accessories.

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Test Result, Device Operational Issue, Incorrect, Inadequate or Imprecise Result or Readings, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Not Applicable, Leak/Splash, Output 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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