Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1560-2020 — 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.

U.S. FDA — Device Enforcement · United States · 2020-02-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1560-2020
Date of alert
2020-02-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Dexcom Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30386270000010
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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