The Recall Desk

FDA (Devices) recall action 84891

Dexcom Inc recalled 3 products on 2020-04-01

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-04-01
Critical
0
Units
364,203

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2020-04-01

    Dexcom G5 and G4 PLATINUM Systems Recalled for Hydroxyurea Interference

    Dexcom Inc is recalling G5 and G4 PLATINUM Continuous Glucose Monitoring Systems because hydroxyurea use may cause falsely elevated glucose readings.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-04-01

    Dexcom G4 Platinum Recall Due to Hydroxyurea Interference

    Dexcom Inc is recalling G4 PLATINUM systems because hydroxyurea use may cause falsely elevated glucose readings.

    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-04-01

    Dexcom G6 Continuous Glucose Monitoring System Recalled for Hydroxyurea Interference

    Dexcom Inc is recalling G6 Continuous Glucose Monitoring Systems because the anti-neoplastic drug hydroxyurea may cause falsely elevated glucose readings.

    Product
    Dexcom G6 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.
    Category
    Distribution
    0 states