Recall Z-1562-2020— Dexcom Inc

Name: FDA recall Z-1562-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-03

Class II · Terminated

Class II FDA medical device recall by Dexcom Inc, initiated 2020-02-03, terminated 2022-01-20. It names one FDA 510(k) clearance: K191450. 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.. 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

510(k) clearances named in this recall

1 on FDA's record

K191450 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring SystemDexcom, Inc.·cleared 2019-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.