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.
Check against the official notice below — it lists the full affected range.
Dexcom Inc. has recalled the Dexcom G4 PLATINUM and Dexcom G5 Continuous Glucose Monitoring Systems 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, potentially leading to incorrect diabetes management decisions. The recall affects approximately 85,529 systems distributed worldwide across multiple sensor kit models, including G4/G5 Sensor Kit 4 Pack versions sold through clinical, retail, and Medicare channels.
The product recall record does not specify a remedy or instructions for affected consumers regarding what actions they should take.
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: 85529 Systems Lot/code info: Device Listing Number: D189069 Model: STS-GL-041 Description: G4/G5 Sensor Kit 4 Pack GUDID Registered GTIN: 30386270000010 Lot Number: All Model: STS-RX-041 Description: G4/G5 Sensor Kit 4 Pack Retail GUDID Registered GTIN: 20386270000013 Lot Number: All Model: STS-MC-004 Description: G4/G5 Sensor Kit 4 Pack Medicare GUDID Registered GTIN: 00386270000637 Lot Number: All
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.