Dexcom G5 Continuous Glucose Monitoring System The recall
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated…
Why was Dexcom G5 Continuous Glucose Monitoring System The 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated…
- Recalling firm
- Dexcom Inc
- Quantity
- 85529 Systems
- Distribution
- World-wide Distribution
- Recall date
- April 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)