Dexcom Inc recalls Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose…

Recall date

February 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1561-2020

FDA classification

Class II

Brand / firm

Dexcom Inc

Sold / distributed

World-wide Distribution

Why it was recalled

The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.