medical Class II Updated 2020-04-01

Dexcom Inc recalls Dexcom G6 Continuous Glucose Monitoring System The Dexcom

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: World-wide Distribution

Lot/Code Info: Device Listing Number: D319131 Model: STS-OR-003 Description: G6 Sensor Kit 3 Pack GUDID Registered GTIN: 50386270000250 Lot Number: All Model: STS-OE-003 Description: G6 Sensor Kit 3 Pack Retail GUDID Registered GTIN: 00386270000866 Lot Number: All Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Medicare GUDID Registered GTIN: 00386270001047 Lot Number: All Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Pro Q GUDID Registered GTIN: 70386270000254 Lot Number: All

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