Z-1562-2020Class II

Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is...

Name: Z-1562-2020 Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is...
Creator: Dexcom Inc
Published: 2020-02-03
License: https://open.fda.gov/license/

Dexcom, Inc. / initiated 2020-02-03 / Terminated

FDA source

Dexcom Inc began a recall of Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for... on 2020-02-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1562-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-03
Posted: 2020-03-25
Terminated: 2022-01-20
Recalling firm: Dexcom, Inc.
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.
Product code: QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
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.
FDA root cause: Under Investigation by firm
Action: Starting in February 2020, the firm will add an "URGENT MEDICAL DEVICE CORRECTION" Notification to sensor packaging informing valued customers that the firm recently became aware that hydroxyurea, an anti-neoplastic drug used primarily in chemotherapy, falsely elevates glucose readings on its Continuous Glucose Monitoring (CGM) Systems. This may result in failure to treat hypoglycemia from missed low sensor glucose values and alerts or by causing other errors in diabetes management decisions (for example, hypoglycemia resulting from an insulin dose based on a falsely elevated sensor glucose reading). Some examples of the disease states that hydroxyurea is more commonly used in include: -Chronic Myelogenous Leukemia (CML) -Head and neck malignancies, and -Sickle cell disease The Recalling Firm is instructing its customers to not use their CGM System for diabetes treatment decisions if they are taking hydroxyurea. Customers are instructed to talk to their physician about alternative glucose monitoring approaches, and if they are unsure if they have been prescribed hydroxyurea. The Recalling Firm is currently updating their product labelling as following: "Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia; it is known to interfere with readings from your sensor. If you are taking hydroxyurea, your sensor glucose readings will be higher than your actual glucose, which could result in missed hypoglycemia alerts, or errors in diabetes management, such as giving yourself a higher dose of insulin due to falsely high sensor glucose values. The level of inaccuracy depends on the amount of hydroxyurea in your body. Do not use your Dexcom CGM System for diabetes treatment decisions if you are taking hydroxyurea. Talk to your physician about alternative glucose monitoring approaches. . . .Should you have any questions regarding hydroxyurea or alternative glucose monitoring approaches, please contact your healthcare
Quantity in commerce: 275583
Distribution: World-wide Distribution
Product codes and lots: Device Listing Number: D319131 Model: STS-OR-003 Description: G6 Sensor Kit 3 Pack GUDID Registered GTIN: 50386270000250 Lot Number: All Model: STS-OE-003 Description: G6 Sensor Kit 3 Pack Retail GUDID Registered GTIN: 00386270000866 Lot Number: All Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Medicare GUDID Registered GTIN: 00386270001047 Lot Number: All Model: STS-OM-003 Description: G6 Sensor Kit 3 Pack Pro Q GUDID Registered GTIN: 70386270000254 Lot Number: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1562-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1560-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-25
Z-1561-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-25
Z-1562-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-25

Product code QBJ

K191450Class IIDexcom 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)