Reported Apr 1, 2020 · Terminated
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is…
Dexcom Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dexcom Inc · 6340 Sequence Dr · San Diego, CA · 92121-4356
Is this the product you have?
- 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.
- Lot codes and dates
- Device Listing NumberD189069
- ModelSTS-GL-041
- DescriptionG4/G5
- Sensor Kit 4 Pack GUDID Registered GTIN30386270000010
- Lot NumberAll
- ModelSTS-RX-041
- DescriptionG4/G5 Sensor
- Kit 4 Pack Retail GUDID Registered GTIN20386270000013
- Lot NumberAll
- ModelSTS-MC-004
- DescriptionG4/G5 Sensor Kit 4
- Pack Medicare GUDID Registered GTIN00386270000637
- Lot NumberAll
- Amount recalled
- 3091 Systems
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Dexcom Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.