Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monit...
FDA Device Recall #Z-1561-2020 — Class II — February 3, 2020
Recall Summary
| Recall Number | Z-1561-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 3, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Dexcom Inc |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 85529 Systems |
Product Description
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.
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.
Distribution Pattern
World-wide Distribution
Lot / Code Information
Device Listing Number: D189069 Model: STS-GL-041 Description: G4/G5 Sensor Kit 4 Pack GUDID Registered GTIN: 30386270000010 Lot Number: All Model: STS-RX-041 Description: G4/G5 Sensor Kit 4 Pack Retail GUDID Registered GTIN: 20386270000013 Lot Number: All Model: STS-MC-004 Description: G4/G5 Sensor Kit 4 Pack Medicare GUDID Registered GTIN: 00386270000637 Lot Number: All
Other Recalls from Dexcom Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1562-2020 | Class II | Dexcom G6 Continuous Glucose Monitoring System ... | Feb 3, 2020 |
| Z-1560-2020 | Class II | Dexcom G4 PLATINUM Continuous Glucose Monitorin... | Feb 3, 2020 |
| Z-1104-2020 | Class II | Brand Name: Dexcom G6 CGM App for iOS Software... | Nov 19, 2019 |
| Z-0929-2020 | Class II | Dexcom Receiver, REF: MT22719, (Black, Pin, Bl... | Jul 12, 2019 |
| Z-1336-2016 | Class I | Dexcom G4 PLATINUM (Professional) Receiver Rec... | Feb 23, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.