Z-1560-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 3, 2020
- Termination Date
- January 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3091 Systems
Product Description
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.
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 Pattern
World-wide Distribution
Code Information
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