FDA Device recall Z-1562-2020
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device i…
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device i… by Dexcom, citing the company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring S….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1562-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-03 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Dexcom |
| Distribution | n/a |
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.
Identifiers
| code_info | Device Listing Number: D319131 Model: STS-OR-003 Description: G6 Sensor Kit 3 Pack GUDID Registered GTIN: 503862…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1562-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.