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.
Check against the official notice below — it lists the full affected range.
Dexcom Inc. is recalling Dexcom G6 Continuous Glucose Monitoring System sensor kits worldwide due to potential interference from hydroxyurea, an anti-neoplastic drug used to treat certain cancers. When patients taking hydroxyurea use these glucose monitoring devices, the readings may be falsely elevated. The recall affects approximately 275,583 units across multiple model variants including the G6 Sensor Kit 3 Pack in Registered, Retail, Medicare, and Pro Q configurations.
The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: World-wide Distribution Quantity: 275583 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.