FDA-Device2020-04-01Class II
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.
Dexcom Inc
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.
Sold states
World-wide Distribution
Affected count
85529 Systems
Manufactured in
6340 Sequence Dr, N/A, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2020Don't want to check this manually?
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