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FDAFebruary 3, 2020device

Dexcom G6 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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

dexcom

UPCs

50386270000250003862700008660038627000104770386270000254

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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