Reported Apr 1, 2020 · Terminated
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose…
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 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.
- Lot codes and dates
- Device Listing NumberD319131
- ModelSTS-OR-003
- DescriptionG6
- Sensor Kit 3 Pack GUDID Registered GTIN50386270000250
- Lot NumberAll
- ModelSTS-OE-003
- DescriptionG6 Sensor
- Kit 3 Pack Retail GUDID Registered GTIN00386270000866
- Lot NumberAll
- ModelSTS-OM-003
- DescriptionG6 Sensor Kit 3
- Pack Medicare GUDID Registered GTIN00386270001047
- Lot NumberAll
- ModelSTS-OM-003
- DescriptionG6 Sensor
- Kit 3 Pack Pro Q GUDID Registered GTIN70386270000254
- Lot NumberAll
- Amount recalled
- 275583
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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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