Dexcom G4 Platinum Recall Due to Hydroxyurea Interference
Dexcom Inc is recalling G4 PLATINUM 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 high-risk medical device where a known drug interaction causes inaccurate readings, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Dexcom Inc is recalling 3,091 units of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System. The recall involves specific sensor kits, including the G4/G5 Sensor Kit 4 Pack (Model STS-GL-041), the G4/G5 Sensor Kit 4 Pack Retail (Model STS-RX-041), and the G4/G5 Sensor Kit 4 Pack Medicare (Model STS-MC-004). The affected devices were distributed worldwide.
The recall was initiated because the company identified potential interference from the anti-neoplastic drug hydroxyurea. Use of this medication may cause the Continuous Glucose Monitoring Systems to display falsely elevated glucose readings. The device is indicated for detecting trends and tracking patterns in persons age 18 and older with diabetes.
Consumers who use the Dexcom G4 PLATINUM system and take hydroxyurea should be aware that their glucose readings may be inaccurate. The source text does not provide specific instructions for consumers on how to proceed or contact the manufacturer.
The recalled product
- Product
- 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.
- Manufacturer
- Dexcom Inc
- Affected units
- 3,091
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.
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