Dexcom Inc: Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracki

Is my product affected?

Dexcom G4 PLATINUM 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.

• UPC 30386270000010
• UPC 20386270000013
• UPC 00386270000637

Check against the official notice below — it lists the full affected range.

What happened

Dexcom Inc. has recalled approximately 3,091 Dexcom G4 PLATINUM Continuous Glucose Monitoring Systems due to potential interference from the drug hydroxyurea. Hydroxyurea is an anti-neoplastic medication, and when patients using this drug wear the glucose monitoring system, the device may display falsely elevated glucose readings. The affected devices were distributed worldwide and include sensor kits in multiple configurations (registered and retail versions).

The recall affects G4/G5 Sensor Kit 4 Packs across all lot numbers in three models: STS-GL-041, STS-RX-041, and STS-MC-004. The source document does not specify what remedy or action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: 3091 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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