Dexcom G5 and G4 PLATINUM Systems Recalled for Hydroxyurea Interference
Dexcom Inc is recalling G5 and G4 PLATINUM Continuous Glucose Monitoring Systems because hydroxyurea use may cause falsely elevated glucose readings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed adverse events.
Plain-English summary
Dexcom Inc is recalling 85,529 units of the Dexcom G5 and Dexcom G4 PLATINUM Continuous Glucose Monitoring Systems. These devices are indicated for detecting trends and tracking patterns in persons age 18 and older with diabetes. The affected products include G4/G5 Sensor Kits in 4-pack configurations for general, retail, and Medicare use, with all lot numbers affected.
The recall was initiated because the company identified potential interference from the anti-neoplastic drug hydroxyurea. Patient use of this medication may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. The recall involves worldwide distribution.
Consumers using these devices who are also taking hydroxyurea should consult their healthcare provider regarding the potential for inaccurate glucose readings. The source text does not specify additional consumer actions or report any illnesses or injuries.
The recalled product
- Product
- 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.
- Manufacturer
- Dexcom Inc
- Affected units
- 85,529
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Dexcom Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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