MAUDE manufacturer profile

TOSOH CORPORATION · LCP

MAUDE profile for Assay, Glycosylated Hemoglobin

Key facts

Manufacturer TOSOH CORPORATION
Manufacturer group TOSOH BIOSCIENCE, INC. (IMPORTER)
Product code LCP
Product code name Assay, Glycosylated Hemoglobin

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, Device Operational Issue, Device Displays Incorrect Message, Device Issue, Mechanical Problem, Incorrect, Inadequate or Imprecise Result or Readings, Increase in Pressure 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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