MAUDE manufacturer profile

ABBOTT POINT OF CARE INC. · MMI

MAUDE profile for Immunoassay Method, Troponin Subunit

Key facts

Manufacturer ABBOTT POINT OF CARE INC.
Manufacturer group ABBOTT POINT OF CARE CANADA LTD.
Product code MMI
Product code name Immunoassay Method, Troponin Subunit

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • False Positive Result, Chest Pain, False Negative Result, No Information, No Clinical Signs, Symptoms or Conditions, Dizziness, Pain, Incorrect Or Inadequate Test Results 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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