Recall Z-1560-2020— Dexcom Inc
Class II · Terminated
Class II FDA medical device recall by Dexcom Inc, initiated 2020-02-03, terminated 2022-01-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Dexcom Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-03
- Terminated
- 2022-01-20
- Firm location
- San Diego, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.